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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Endoscope Maintenance System
510(k) Number K860246
Device Name ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE
Applicant
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number876.1500
Classification Product Code
PUP  
Date Received01/24/1986
Decision Date 04/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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