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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 K871901
Device Name ULTRAFLOW
Applicant
Custom Industries, Inc.
6106 W. Market St.
P.O. Box 18547
Greensboro,  NC  27409
Applicant Contact JERRY C LAMBERT
Correspondent
Custom Industries, Inc.
6106 W. Market St.
P.O. Box 18547
Greensboro,  NC  27409
Correspondent Contact JERRY C LAMBERT
Regulation Number878.5070
Classification Product Code
FZH  
Date Received05/15/1987
Decision Date 06/01/1987
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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