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510(k) K945002

1X6YD, 2X6YD, 4X6YD ROLL BANDAGE by Certified Safety Mfg., Inc. — Product Code EFQ

K945002 is an FDA 510(k) premarket notification submitted by Certified Safety Mfg., Inc. for the device "1X6YD, 2X6YD, 4X6YD ROLL BANDAGE". The FDA issued a decision of Substantially Equivalent on March 22, 1995. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Certified Safety Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1995
Date Received
October 13, 1994
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 Certified Safety Mfg., Inc.

  • K960587 — CPROTECTOR 2000 (July 21, 1997)
  • K960615 — GAUZE COMPRESS (November 25, 1996)
  • K960624 — CERTI COOL INSTANT COLD COMPRESS (May 6, 1996)
  • K953102 — BLOODBORNE PATHOGEN KIT (December 11, 1995)
  • K946338 — CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING (March 29, 1995)
  • K945004 — 2, 3 & 4 BANDADGE COMPRESS (March 22, 1995)
  • K940249 — CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING (October 3, 1994)
  • K941311 — FIRST AID/TRUMA KIT (June 14, 1994)
  • K940358 — X-LARGE MULTI-FUNCTION TRAUMA DRESSING (March 23, 1994)
  • K940333 — EYE PAD (March 7, 1994)

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