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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 K854902
Device Name SURGICOT STEAM TEST PACK
Applicant
SURGICOT, INC.
55 KENNEDY DR.
SMITHTOWN,  NY  11787
Applicant Contact JAMES BROWN
Correspondent
SURGICOT, INC.
55 KENNEDY DR.
SMITHTOWN,  NY  11787
Correspondent Contact JAMES BROWN
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/09/1985
Decision Date 05/20/1986
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
Recalls CDRH Recalls
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