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510(k) K924650

GAUZE SPONGES by Dav-Mar Medical Products, Inc. — Product Code NAB

K924650 is an FDA 510(k) premarket notification submitted by Dav-Mar Medical Products, Inc. for the device "GAUZE SPONGES". The FDA issued a decision of Substantially Equivalent on January 11, 1993. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Dav-Mar Medical Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1993
Date Received
September 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 Dav-Mar Medical Products, Inc.

  • K936216 — STERILE GAUZE SPONGES (March 9, 1994)

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)
  • K923602 — ABSORBENT PAD -- MODIFICATION (December 7, 1992)
  • 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