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510(k) K912954

STRETCH GAUZE BANDAGE by Cal West Trading Co. — Product Code NAB

K912954 is an FDA 510(k) premarket notification submitted by Cal West Trading Co. for the device "STRETCH GAUZE BANDAGE". The FDA issued a decision of Substantially Equivalent on September 10, 1991. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. Cal West Trading Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1991
Date Received
July 2, 1991
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 Cal West Trading Co.

  • K950392 — 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 (February 21, 1995)
  • K933756 — MAGNASHIELD CPR MOUTH BARRIER (January 5, 1994)
  • K920269 — EZ GAUZE SPONGE (April 22, 1992)
  • K914842 — GAUZE BANDAGE ROLL (December 4, 1991)
  • K912950 — COMPRESS DRESSING (October 4, 1991)
  • K912952 — BANDAGE COMPRESS (October 4, 1991)
  • K912953 — GAUZE COMPRESS (September 30, 1991)
  • K912951 — 12-PLY GAUZE PAD (September 10, 1991)
  • K912955 — EYE PAD (September 10, 1991)
  • K912949 — TRIANGULAR BANDAGE,40 (September 6, 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