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510(k) K912955

EYE PAD by Cal West Trading Co. — Product Code EFQ

K912955 is an FDA 510(k) premarket notification submitted by Cal West Trading Co. for the device "EYE PAD". The FDA issued a decision of Substantially Equivalent on September 10, 1991. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. 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, Internal
Device Class
Class U
Regulation Number
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)
  • K912954 — STRETCH GAUZE BANDAGE (September 10, 1991)
  • K912951 — 12-PLY GAUZE PAD (September 10, 1991)
  • K912949 — TRIANGULAR BANDAGE,40 (September 6, 1991)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources