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510(k) K923846

BURN DRESSING by Medical Action Industries, Inc. — Product Code NAB

K923846 is an FDA 510(k) premarket notification submitted by Medical Action Industries, Inc. for the device "BURN DRESSING". The FDA issued a decision of Substantially Equivalent on September 11, 1992. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Medical Action Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1992
Date Received
July 31, 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 Medical Action Industries, Inc.

  • K042526 — DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON S (April 25, 2005)
  • K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (November 8, 2004)
  • K022948 — VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L (November 4, 2002)
  • K946019 — SURGICLA INSTRUMENT KIT (March 20, 1995)
  • K884826 — GAUZE SPONGE (December 22, 1988)
  • K810685 — SUTURE REMOVAL KIT (March 26, 1981)
  • K810184 — LAPAROTOMY SPONGE (February 4, 1981)

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