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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Freezer
510(k) Number K894006
Device Name SANISERV SURGICAL SLUSH SYSTEM
Applicant
Saniserv, Inc.
P.O. Box 41240
2020 Production Dr.
Indianapolis,  IN  46241
Applicant Contact JACK FARLEY
Correspondent
Saniserv, Inc.
P.O. Box 41240
2020 Production Dr.
Indianapolis,  IN  46241
Correspondent Contact JACK FARLEY
Regulation Number862.2050
Classification Product Code
JRM  
Date Received06/05/1989
Decision Date 11/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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