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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Monitor, Spine Curvature
510(k) Number K902669
Device Name BPA, BODY POSITION ALARM
Applicant
Bagrad
375 Glendening Rd.
Orange Park,  FL  32073
Applicant Contact SHAWN GALLAGHER
Correspondent
Bagrad
375 Glendening Rd.
Orange Park,  FL  32073
Correspondent Contact SHAWN GALLAGHER
Classification Product Code
LZW  
Date Received06/18/1990
Decision Date 07/27/1990
Decision Substantially Equivalent (SESE)
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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