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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K963462
Device Name COMFOR FOAM LIMB HOLDERS- SINGLE STRAP
Applicant
BIRD & CRONIN, INC.
1200 TRAPP RD.
SAINT PAUL,  MN  55121
Applicant Contact MICHAEL FRAZER
Correspondent
BIRD & CRONIN, INC.
1200 TRAPP RD.
SAINT PAUL,  MN  55121
Correspondent Contact MICHAEL FRAZER
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/03/1996
Decision Date 11/21/1996
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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