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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 K891467
Device Name LOKSHOT PISTON SYRINGE
Applicant
Flp Ent., Inc.
21a Sweetser St.
Wakefield,  MA  01880
Applicant Contact FREDERICK L PLOUFF
Correspondent
Flp Ent., Inc.
21a Sweetser St.
Wakefield,  MA  01880
Correspondent Contact FREDERICK L PLOUFF
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/15/1989
Decision Date 05/24/1989
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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