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510(k) K896127

THORA-KLEX CHEST DRAINAGE UNIT by Davol, Inc. — Product Code KDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1990
Date Received
October 23, 1989
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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  • K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2- (August 28, 1996)
  • K961287 — ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (July 26, 1996)
  • K962168 — MUCUS SPECIMEN TRAP (July 22, 1996)
  • K950677 — ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (April 13, 1995)
  • K941818 — PM9000 VAC TRAP (December 12, 1994)
  • K932327 — THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (July 13, 1993)