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510(k) K970721

DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM by Johnson & Johnson Medical, Inc. — Product Code MCY

K970721 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM". The FDA issued a decision of SN on March 21, 1997. The device falls under product code MCY (Wound Dressing Kit), a Class II device regulated under 21 CFR 880.5075. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 21, 1997
Date Received
February 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing Kit
Device Class
Class II
Regulation Number
880.5075
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Johnson & Johnson Medical, Inc.

  • K033523 — COLLAGEN-ORC ANTIMICROBIAL MATRIX (October 21, 2004)
  • K022483 — ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING (February 3, 2003)
  • K014129 — PROMOGRAN MATRIX WOUND DRESSING (February 14, 2002)
  • K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (July 31, 2000)
  • K982641 — ADVANCED NIBP MODULE (March 29, 1999)
  • K983362 — NU-GEL * WOUND DRESSING (December 16, 1998)
  • K982597 — FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (August 20, 1998)
  • K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF (May 18, 1998)
  • K980493 — I.V. CATHETER SYSTEM (April 28, 1998)
  • K972498 — OBSERVER * CENTRAL STATION (February 17, 1998)

Other clearances for product code MCY

  • K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (November 27, 1996)
  • K960585 — WOUND CARE COMPRESSION SYSTEM (WCCS) (April 26, 1996)
  • K952334 — DRESSING CHANGE TRAY (July 14, 1995)
  • K951022 — CIRCULON SYSTEM STEP 1 (June 12, 1995)
  • K951021 — CIRCULON SYSTEM STEP 2 (June 12, 1995)
  • K951476 — E-PACK PROCEDURE KITS (May 23, 1995)
  • K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
  • K924690 — VARIOUS NON-STERILE CUSTOM TRAYS/KITS (July 16, 1993)
  • K923905 — WOUND DRESSING KIT (July 2, 1993)
  • K925021 — TPN TRAY (STERILE) (June 7, 1993)

FDA data resources