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510(k) K962856

PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR by Deknatel, Inc. — Product Code KDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1996
Date Received
July 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Collection, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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  • K964070 — DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG (December 31, 1996)
  • K963098 — PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM( (November 8, 1996)
  • K925243 — DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER (July 27, 1994)
  • K926338 — PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F (July 26, 1994)
  • K930739 — SUTURES POLYPROP., POLYETHELINE, NYLON & SILK (July 26, 1994)
  • K930740 — SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL (July 26, 1994)
  • K930738 — SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC (July 26, 1994)
  • K931106 — BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT (October 6, 1993)

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