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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 K891125
Device Name CONSTRICTOR RING FOR PENILE ERECTION
Applicant
Performance, Inc.
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
Performance, Inc.
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number876.5020
Classification Product Code
LKY  
Date Received03/03/1989
Decision Date 04/27/1989
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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