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510(k) K923602

ABSORBENT PAD -- MODIFICATION by Winfield Laboratories, Inc. — Product Code NAB

K923602 is an FDA 510(k) premarket notification submitted by Winfield Laboratories, Inc. for the device "ABSORBENT PAD -- MODIFICATION". The FDA issued a decision of Substantially Equivalent on December 7, 1992. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Winfield Laboratories, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1992
Date Received
July 15, 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 Winfield Laboratories, Inc.

  • K973538 — N-TERFACE (December 16, 1997)
  • K872069 — KONTOUR ULTRA SOFT SPONGE #SS144.50 (July 14, 1987)
  • K820198 — DERMA-AID (March 5, 1982)

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)
  • K923115 — CLINISORB (November 23, 1992)
  • K923378 — USP TYPE VII GAUZE SPONGES (October 6, 1992)
  • K923116 — COMBINE II WETPROOF PAD (October 6, 1992)

FDA data resources