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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 K851464
Device Name PULSE MED CUSTOM PKG. PROC. TRAYS OPERATING ROOMS
Applicant
Pulse Med, Inc.
12919 Alcosta Blvd.
Suite 9
San Ramon,  CA  94583
Applicant Contact CLIFFORD E KNUCKLES
Correspondent
Pulse Med, Inc.
12919 Alcosta Blvd.
Suite 9
San Ramon,  CA  94583
Correspondent Contact CLIFFORD E KNUCKLES
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/11/1985
Decision Date 07/05/1985
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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