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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral
510(k) Number K913477
Device Name APEX(TM) PROSTATIC BALLOON DILATION CATHETER
Applicant
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact JESSICA AYRES
Correspondent
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact JESSICA AYRES
Regulation Number876.5520
Classification Product Code
KOE  
Date Received08/05/1991
Decision Date 12/27/1991
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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