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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Battery-Powered And Accessories
510(k) Number K931340
Device Name GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR
Applicant
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Applicant Contact DAPHNE D MAURER
Correspondent
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Correspondent Contact DAPHNE D MAURER
Regulation Number876.1500
Classification Product Code
GCS  
Date Received03/16/1993
Decision Date 07/01/1993
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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