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FDA 510(k) Application Details - K100726
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K100726
Device Name
Powered Laser Surgical Instrument
Applicant
BIOLITEC, INC.
1349 MAIN ROAD
GRANVILLE, MA 01034 US
Other 510(k) Applications for this Company
Contact
HARRY HAYES
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/15/2010
Decision Date
09/15/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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