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510(k) K080524

CENTURION SORBAVIEW OTC by Tri-State Hospital Supply Corp. — Product Code NAD

K080524 is an FDA 510(k) premarket notification submitted by Tri-State Hospital Supply Corp. for the device "CENTURION SORBAVIEW OTC". The FDA issued a decision of Substantially Equivalent on April 23, 2008. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Tri-State Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2008
Date Received
February 26, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Tri-State Hospital Supply Corp.

  • K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES (August 28, 2008)
  • K942353 — CENTURION UMBILICAL CATHETER (August 15, 1995)
  • K945977 — CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING (March 29, 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 NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)
  • K960815 — DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSIN (April 29, 1996)

FDA data resources