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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 K851646
Device Name VIBRECTOR
Applicant
Multicept, Aps.
Gentoftegade 83
2820 Geneofte
Copenhagen,  DK
Applicant Contact JAKOB WAGNER
Correspondent
Multicept, Aps.
Gentoftegade 83
2820 Geneofte
Copenhagen,  DK
Correspondent Contact JAKOB WAGNER
Classification Product Code
LIL  
Date Received04/19/1985
Decision Date 08/21/1985
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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