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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Ultrasonic, Medical Instrument
510(k) Number K931270
Device Name SURGICLEAN ENZYMATIC INSTRUMENT CLEANER
Applicant
SURGICOT, INC.
ONE PARK CENTER
PATRIOT DR.,PO BOX 13956
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact GLENN MATTEI
Correspondent
SURGICOT, INC.
ONE PARK CENTER
PATRIOT DR.,PO BOX 13956
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact GLENN MATTEI
Regulation Number880.6150
Classification Product Code
FLG  
Date Received03/08/1993
Decision Date 04/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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