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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K912903
Device Name PERCUTANEOUS RETRACTOR KIT
Applicant
Applied Urology, Inc.
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
Applied Urology, Inc.
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/02/1991
Decision Date 08/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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