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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Pneumatic
510(k) Number K871982
Device Name TOURNIQUET PRESSURE REGULATOR
Applicant
Avec Scientific Design Corp.
605 S. 19th St.
Philadelphia,  PA  19146
Applicant Contact AARON HEINTZ
Correspondent
Avec Scientific Design Corp.
605 S. 19th St.
Philadelphia,  PA  19146
Correspondent Contact AARON HEINTZ
Regulation Number878.5910
Classification Product Code
KCY  
Date Received05/22/1987
Decision Date 06/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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