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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 K832121
Device Name DACOMED SNAP-GAUGE
Applicant
Dacomed Corp.
MD 
Correspondent
Dacomed Corp.
MD 
Classification Product Code
LIL  
Date Received06/30/1983
Decision Date 07/18/1983
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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