FDA 510(k) Application Details - K051631

Device Classification Name Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

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510(K) Number K051631
Device Name Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Applicant STARGATE INTERNATIONAL, INC.
10235 SOUTH PROGRESS WAY, #7
PARKER, CO 80134 US
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Contact ROBERT H WALKER
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Regulation Number 890.5500

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Classification Product Code NHN
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Date Received 06/20/2005
Decision Date 07/27/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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