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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K911190
Device Name PERRYMETER(TM)
Applicant
Perrymeter Systems
242 Old Eagle School Rd.
Strafford
Philadelphia,  PA  19087
Applicant Contact JOHN D PERRY
Correspondent
Perrymeter Systems
242 Old Eagle School Rd.
Strafford
Philadelphia,  PA  19087
Correspondent Contact JOHN D PERRY
Regulation Number884.1425
Classification Product Code
HIR  
Date Received03/18/1991
Decision Date 07/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
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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