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510(k) K833549

PDI SURGICAL SCRUB/BRUSH T150-70 by Nice-Pak Products, Inc. — Product Code NAB

K833549 is an FDA 510(k) premarket notification submitted by Nice-Pak Products, Inc. for the device "PDI SURGICAL SCRUB/BRUSH T150-70". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Nice-Pak Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
September 1, 1983
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 Nice-Pak Products, Inc.

  • K974768 — PDI STERILE LUBRICATING JELLY (January 16, 1998)
  • K840342 — PDI PREPMASTER WET PACK PATIENT PREP KIT (March 27, 1984)
  • K840343 — PDI PREPMASTER WET PACK VAGINAL-X21477 (March 27, 1984)
  • K840344 — PDI PREPMASTER WET PACK MINOR PROCEDURE (March 26, 1984)
  • K810337 — PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 (February 26, 1981)
  • K781539 — ISO-CARE KIT (November 3, 1978)
  • K780279 — ICE-PAK, PDI (April 10, 1978)
  • K780400 — DEN-Z-ORB (March 27, 1978)

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