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510(k) K920282

PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE by Trinity Laboratories, Inc. — Product Code NAB

K920282 is an FDA 510(k) premarket notification submitted by Trinity Laboratories, Inc. for the device "PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on May 29, 1992. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Trinity Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1992
Date Received
January 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze / Sponge,Nonresorbable For External Use
Device Class
Class I
Regulation Number
878.4014
Review Panel
SU
Submission Type

Other clearances by Trinity Laboratories, Inc.

  • K981441 — HEART CATH TRAY, STERILE, DISPOSABLE (July 10, 1998)
  • K974238 — DENTAL TRAY, STERILE, DISPOSABLE (February 4, 1998)
  • K974286 — CIRCUMCISION TRAY, CAT. NO. 70340 (December 12, 1997)
  • K972160 — CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATIO (August 1, 1997)
  • K970722 — EYE TRAY (March 31, 1997)
  • K965201 — O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (February 14, 1997)
  • K964921 — BASIC BIOPSY TRAY. DISPOSABLE, STERILE (January 22, 1997)
  • K953929 — MID-STREAM COLLECTION SET-STERILE (November 16, 1995)
  • K952058 — STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE (September 21, 1995)
  • K953070 — WOUNDFOAM 4 X 4 (September 8, 1995)

Other clearances for product code NAB

  • K946015 — IVALON EXTERNAL SPONGE (February 27, 1995)
  • K940755 — ISOLYER (4X4, 8PLY) (May 2, 1994)
  • K931610 — OMNISORB II, NONWOVEN SPONGE, STERILE AND NON (June 24, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K926072 — K-BAND AND K-CREPE (March 19, 1993)
  • K915591 — STERILE GAUZE PADS (January 27, 1993)
  • K924650 — GAUZE SPONGES (January 11, 1993)
  • K923602 — ABSORBENT PAD -- MODIFICATION (December 7, 1992)
  • K923115 — CLINISORB (November 23, 1992)
  • K923378 — USP TYPE VII GAUZE SPONGES (October 6, 1992)

FDA data resources