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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K881332
Device Name DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
Applicant
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Applicant Contact PAUL R GOTH
Correspondent
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Correspondent Contact PAUL R GOTH
Regulation Number876.1500
Classification Product Code
OCZ  
Subsequent Product Code
FDX  
Date Received03/29/1988
Decision Date 04/27/1988
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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