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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 K861468
Device Name IMPAX, MALE IMPOTENCE AID
Applicant
Lehigh Group
Fishers Ln. Consultants
111 Silver Hill Rd.
Concord,  MA  01742
Applicant Contact C/O D CARABILLO
Correspondent
Lehigh Group
Fishers Ln. Consultants
111 Silver Hill Rd.
Concord,  MA  01742
Correspondent Contact C/O D CARABILLO
Regulation Number876.5020
Classification Product Code
LKY  
Date Received04/21/1986
Decision Date 06/18/1986
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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