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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 K941348
Device Name KRONNER LAPAROSCOPIC HOLDER
Applicant
Kronner Prototypes, Inc.
171 Medical Loop Rd.
Suite 150
Roseburg,  OR  97470
Applicant Contact RICHARD F KRONNER,M.D
Correspondent
Kronner Prototypes, Inc.
171 Medical Loop Rd.
Suite 150
Roseburg,  OR  97470
Correspondent Contact RICHARD F KRONNER,M.D
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/21/1994
Decision Date 11/14/1994
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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