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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Board, Arm (With Cover), Sterile
510(k) Number K900175
Device Name 4/1 ARMBOARD
Applicant
Infection Control Products, Inc.
P.O. Drawer 739
1019 Grubbs Ave.
Gardendale,  AL  35071
Applicant Contact PATRICK RUSSELL
Correspondent
Infection Control Products, Inc.
P.O. Drawer 739
1019 Grubbs Ave.
Gardendale,  AL  35071
Correspondent Contact PATRICK RUSSELL
Regulation Number878.3910
Classification Product Code
BTX  
Date Received01/12/1990
Decision Date 01/24/1990
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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