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510(k) K941818

PM9000 VAC TRAP by Precision Medical, Inc. — Product Code KDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1994
Date Received
April 13, 1994
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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  • K932327 — THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (July 13, 1993)
  • K912704 — ATRIUM 2000 CHEST DRAIN (August 26, 1991)