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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 K905195
Device Name FIRM MASTER
Applicant
Bak Medical Products
1125b Arnold Dr.
Suite 257
Martinez,  CA  94553
Applicant Contact DANIEL MERRILL
Correspondent
Bak Medical Products
1125b Arnold Dr.
Suite 257
Martinez,  CA  94553
Correspondent Contact DANIEL MERRILL
Regulation Number876.5020
Classification Product Code
LKY  
Date Received11/19/1990
Decision Date 02/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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