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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K905718
Device Name ROMFLEX
Applicant
Paraflex Corp.
151 E. Broad St.
Clinton,  TN  37716
Applicant Contact HARRISON BEAL
Correspondent
Paraflex Corp.
151 E. Broad St.
Clinton,  TN  37716
Correspondent Contact HARRISON BEAL
Regulation Number890.5380
Classification Product Code
BXB  
Date Received12/21/1990
Decision Date 02/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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