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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K852990
Device Name PAO VALUE
Applicant
Ackard Laboratories
70 Jackson Dr.
P.O. Box 1085
Cranford,  NJ  07016
Applicant Contact BERNARD ACKERMAN
Correspondent
Ackard Laboratories
70 Jackson Dr.
P.O. Box 1085
Cranford,  NJ  07016
Correspondent Contact BERNARD ACKERMAN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/15/1985
Decision Date 09/20/1985
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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