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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Cleaning, For Endoscope
510(k) Number K850268
Device Name SPARCO SCOPE GUARD
Applicant
Sparco, Inc.
P.O. Box 20369
Castro Valley,  CA  94546
Applicant Contact BEVERLY J SPARKS
Correspondent
Sparco, Inc.
P.O. Box 20369
Castro Valley,  CA  94546
Correspondent Contact BEVERLY J SPARKS
Regulation Number876.1500
Classification Product Code
FEB  
Date Received01/23/1985
Decision Date 04/15/1985
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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