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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Penile Tumescence
510(k) Number K875333
Device Name SURGITEK NPT MONITOR
Applicant
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Applicant Contact WAXBERG
Correspondent
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Correspondent Contact WAXBERG
Classification Product Code
LIL  
Date Received12/30/1987
Decision Date 04/13/1988
Decision Substantially Equivalent (SESE)
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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