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FDA 510(k) Application Details - K010046
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K010046
Device Name
Powered Laser Surgical Instrument
Applicant
AMERICAN LASER CORP.
2417 SOUTH 3850 WEST
SALT LAKE CITY, UT 84120 US
Other 510(k) Applications for this Company
Contact
DANIEL HOEFER
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
01/05/2001
Decision Date
04/05/2001
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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