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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 K913694
Device Name PALCO LABS LOADMATIC
Applicant
Palco Laboratories, Inc.
8030 Soquel Ave.
Santa Cruz,  CA  95062
Applicant Contact PAUL D LEVIN
Correspondent
Palco Laboratories, Inc.
8030 Soquel Ave.
Santa Cruz,  CA  95062
Correspondent Contact PAUL D LEVIN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/19/1991
Decision Date 12/17/1991
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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