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510(k) K830473

NOVA GAUZE by American Threshold Industries, Inc. — Product Code NAB

K830473 is an FDA 510(k) premarket notification submitted by American Threshold Industries, Inc. for the device "NOVA GAUZE". The FDA issued a decision of Substantially Equivalent on April 15, 1983. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. American Threshold Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1983
Date Received
February 15, 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 American Threshold Industries, Inc.

  • K971483 — SECURE-WRAP (TM) STERILIZATION WRAP (June 24, 1997)
  • K953878 — BOUFFANT CAP (January 5, 1996)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K952114 — KOOL GARD SINGLES GOWN (September 25, 1995)
  • K952115 — BARRIER GOWN, KOOL-GARD BACKLESS GOWN (September 25, 1995)
  • K952116 — COVER GOWN (September 5, 1995)
  • K934085 — MODIFICATION OF SURGICAL EYESHIELD MASK (November 12, 1993)
  • K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)
  • K915740 — DISPOSABLE O.R. TOWEL, STERILE (June 22, 1992)
  • K912110 — DISPOSABLE O.R. TOWEL (July 25, 1991)

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