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FDA 510(k) Application Details - K063574
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
K063574
Device Name
Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Applicant
MEDICAL LASER SYSTEMS INC
800 CONNECTICUT AVE. NW
SUITE 500
WAHINGTON, DC 20006 US
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Contact
MIKI KOLTON
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Regulation Number
890.5500
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Classification Product Code
NHN
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Date Received
11/29/2006
Decision Date
01/29/2007
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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