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510(k) K940895

EPIVIEW by Convatec, A Bristol-Myers Squibb Co. — Product Code MGP

K940895 is an FDA 510(k) premarket notification submitted by Convatec, A Bristol-Myers Squibb Co. for the device "EPIVIEW". The FDA issued a decision of SN on November 22, 1994. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Convatec, A Bristol-Myers Squibb Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 22, 1994
Date Received
February 24, 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 Convatec, A Bristol-Myers Squibb Co.

  • K032734 — CONVATEC FECAL MANAGEMENT SYSTEM (April 8, 2004)
  • K990368 — DUODERM HYDROACTIVE GEL WOUND DRESSING (March 26, 1999)
  • K982116 — AQUACEL HYDROFIBER WOUND DRESSING (September 8, 1998)
  • K973806 — DUODERM HYDROACTIVE GEL (December 29, 1997)
  • K973807 — DUODERM HYDROACTIVE PASTE (December 23, 1997)
  • K973716 — DUODERM EXTRA THIN CGF DRESSING (December 17, 1997)
  • K973717 — COMBIDERM ACD (December 17, 1997)
  • K954918 — COMBIDERM ACD (December 26, 1995)
  • K942941 — CONQUEST MALE CONTINENCE SYSTEM (March 17, 1995)

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