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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 K873177
Device Name DEVINE (SUPRAPUBIC SOUND AND GUIDE)
Applicant
Penn Medical Devices, Inc.
12 Ridge St.
Basking Ridge,  NJ  07920
Applicant Contact CHARLES E MEISCH
Correspondent
Penn Medical Devices, Inc.
12 Ridge St.
Basking Ridge,  NJ  07920
Correspondent Contact CHARLES E MEISCH
Regulation Number876.5520
Classification Product Code
KOE  
Date Received08/12/1987
Decision Date 10/14/1987
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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