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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Air Handling, Room
510(k) Number K875305
Device Name MODEL UCA / SPEC SYSTEM UCA
Applicant
Spec Systems, Inc.
P.O. Box 644
701 Lake Dr.
Kernersville,  NC  27285
Applicant Contact LEWIS D MITCHELL
Correspondent
Spec Systems, Inc.
P.O. Box 644
701 Lake Dr.
Kernersville,  NC  27285
Correspondent Contact LEWIS D MITCHELL
Regulation Number878.5070
Classification Product Code
FZH  
Date Received12/29/1987
Decision Date 01/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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