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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K973747
Device Name CONTROLLED TEMPERATURE CABINET SYSTEM
Applicant
Smith
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact DURWARD FARIES, JR.
Correspondent
Smith
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact DURWARD FARIES, JR.
Classification Product Code
LDQ
Date Received10/01/1997
Decision Date 05/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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