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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name manipulator, plunger-like joint
510(k) Number K160278
Device Name VSTAAR AdjusteR
Applicant
SPINAL ACOUSTICS, LLC
640 FOURTH STREET
BEAVER,  PA  15009
Applicant Contact ALBERT A. TORRENCE
Correspondent
SPINAL ACOUSTICS, LLC
640 FOURTH STREET
BEAVER,  PA  15009
Correspondent Contact ALBERT A. TORRENCE
Classification Product Code
LXM  
Date Received02/02/2016
Decision Date 11/04/2016
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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