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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K844942
Device Name PLURA-GARD CHEST DRAINAGE SYSTEM
Applicant
CONSOLIDATED MEDICAL EQUIPMENT, INC.
310 BROAD ST.
UTICA,  NY  13501
Applicant Contact WILLIAM W ABRAHAM
Correspondent
CONSOLIDATED MEDICAL EQUIPMENT, INC.
310 BROAD ST.
UTICA,  NY  13501
Correspondent Contact WILLIAM W ABRAHAM
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received12/20/1984
Decision Date 03/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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