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FDA 510(k) Application Details - K121920
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K121920
Device Name
Laser, Comb, Hair
Applicant
SUNETICS INTERNATIONAL MARKETING GROUP, LLC
892 STEGER TOWNE RD #44
ROCKWALL, TX 75032 US
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Contact
JOHN CARULLO
Other 510(k) Applications for this Contact
Regulation Number
890.5500
More FDA Info for this Regulation Number
Classification Product Code
OAP
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More FDA Info for this Product Code
Date Received
07/02/2012
Decision Date
06/27/2013
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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