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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 K970272
Device Name PATIENT RESTRAINT
Applicant
Fla Orthopedics, Inc.
5858 NW 158th St.,
P.O. Box 5380
Miami Lakes,  FL  33014 -1380
Applicant Contact RHONDA FALK
Correspondent
Fla Orthopedics, Inc.
5858 NW 158th St.,
P.O. Box 5380
Miami Lakes,  FL  33014 -1380
Correspondent Contact RHONDA FALK
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received01/23/1997
Decision Date 04/11/1997
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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