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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K872867
Device Name BIOSIGN
Applicant
Clinical Technology Corp.
3750 Monroe Ave.
P.O. Box 23245
Rochester,  NY  14692
Applicant Contact SCOVILLE, JR
Correspondent
Clinical Technology Corp.
3750 Monroe Ave.
P.O. Box 23245
Rochester,  NY  14692
Correspondent Contact SCOVILLE, JR
Regulation Number880.2800
Classification Product Code
FRC  
Date Received07/21/1987
Decision Date 07/06/1988
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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