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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 K951980
Device Name COLLAPSIBLE HYPODERMIC SYRINGE
Applicant
Roman Vladimirsky
2700 N. Cahuenga Blvd.,
#3109
Los Angeles,  CA  90068
Applicant Contact ROMAN VLADIMIRSKY
Correspondent
Roman Vladimirsky
2700 N. Cahuenga Blvd.,
#3109
Los Angeles,  CA  90068
Correspondent Contact ROMAN VLADIMIRSKY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/27/1995
Decision Date 09/22/1995
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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