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510(k) K931610

OMNISORB II, NONWOVEN SPONGE, STERILE AND NON by Omni Mfg., Inc. — Product Code NAB

K931610 is an FDA 510(k) premarket notification submitted by Omni Mfg., Inc. for the device "OMNISORB II, NONWOVEN SPONGE, STERILE AND NON". The FDA issued a decision of Substantially Equivalent on June 24, 1993. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1993
Date Received
April 1, 1993
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 for product code NAB

  • K946015 — IVALON EXTERNAL SPONGE (February 27, 1995)
  • K940755 — ISOLYER (4X4, 8PLY) (May 2, 1994)
  • 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)
  • K923116 — COMBINE II WETPROOF PAD (October 6, 1992)

FDA data resources