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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 K861276
Device Name TAMPER PROOF CAP
Applicant
Intl. Medical Industries
570 Pleasant St.
Watertown,  MA  02172
Applicant Contact JOHN P VITELLO
Correspondent
Intl. Medical Industries
570 Pleasant St.
Watertown,  MA  02172
Correspondent Contact JOHN P VITELLO
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/07/1986
Decision Date 05/05/1986
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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