Home / 510(k) Clearances / K945977

510(k) K945977

CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING by Tri-State Hospital Supply Corp. — Product Code MGP

K945977 is an FDA 510(k) premarket notification submitted by Tri-State Hospital Supply Corp. for the device "CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM 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. Tri-State Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1995
Date Received
December 8, 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 Tri-State Hospital Supply Corp.

  • K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES (August 28, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K942353 — CENTURION UMBILICAL CATHETER (August 15, 1995)
  • K931748 — CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS (February 25, 1994)
  • K935491 — CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) (February 17, 1994)
  • K923812 — CENTURION DISPOSABLE INSTRUMENTS (December 17, 1992)
  • K910906 — CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS (April 1, 1991)
  • K897100 — CENTURION VAGINAL SPECULUM (March 16, 1990)
  • K896320 — CENTURION KLEEN-NEEDLE SYSTEM (January 11, 1990)
  • K893647 — COPOLYESTER FILM DRESSING (October 16, 1989)

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