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510(k) K080524

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

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.

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  • 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)

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  • 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)