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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Penile
510(k) Number K952841
Device Name THE ASSISTANT
Applicant
Apple Medical Corp.
580 Main St.
Bolton,  MA  01740
Applicant Contact SCOTT E COLERIDGE
Correspondent
Apple Medical Corp.
580 Main St.
Bolton,  MA  01740
Correspondent Contact SCOTT E COLERIDGE
Regulation Number876.5160
Classification Product Code
FHA  
Date Received06/21/1995
Decision Date 08/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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