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FDA 510(k) Application Details - K060305
Device Classification Name
Laser, Comb, Hair
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510(K) Number
K060305
Device Name
Laser, Comb, Hair
Applicant
LEXINGTON INTERNATIONAL, LLC
1700 PENNSYLVANIA AVENUE, NW
WASHINGTON, DC 20006 US
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Contact
EDWARD BASILE
Other 510(k) Applications for this Contact
Regulation Number
890.5500
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Classification Product Code
OAP
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More FDA Info for this Product Code
Date Received
02/06/2006
Decision Date
01/18/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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