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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, External Penile Rigidity
510(k) Number K900559
Device Name RESPONSE EXTERNAL PENILE RIGIDITY DEVICE
Applicant
Smith-Collins Pharmaceutical, Inc.
889 S. Matlack St.
West Chester,  PA  19382
Applicant Contact WILLIAM KNEPSHIELD
Correspondent
Smith-Collins Pharmaceutical, Inc.
889 S. Matlack St.
West Chester,  PA  19382
Correspondent Contact WILLIAM KNEPSHIELD
Regulation Number876.5020
Classification Product Code
LKY  
Date Received02/07/1990
Decision Date 05/02/1990
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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