Home / 510(k) Clearances / K946338

510(k) K946338

CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING by Certified Safety Mfg., Inc. — Product Code MGP

K946338 is an FDA 510(k) premarket notification submitted by Certified Safety Mfg., Inc. for the device "CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING". The FDA issued a decision of Substantially Equivalent on March 29, 1995. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), 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 29, 1995
Date Received
December 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive
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)
  • K945004 — 2, 3 & 4 BANDADGE COMPRESS (March 22, 1995)
  • K945002 — 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE (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 MGP

  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (December 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (October 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (September 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (March 3, 1999)

FDA data resources