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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 K922212
Device Name MDT CASTLE BIOSIGN TEST PACK
Applicant
Mdt Corp., Inc.
1777 E. Henrietta Rd.(14623)
P.O. Box 23077
Rochester,  NY  14692
Applicant Contact MARK N SMITH
Correspondent
Mdt Corp., Inc.
1777 E. Henrietta Rd.(14623)
P.O. Box 23077
Rochester,  NY  14692
Correspondent Contact MARK N SMITH
Regulation Number880.2800
Classification Product Code
FRC  
Date Received05/12/1992
Decision Date 08/10/1992
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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