FDA 510(k) Application Details - K930789

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K930789
Device Name Powered Laser Surgical Instrument
Applicant SUNRISE TECHNOLOGIES, INC.
47257 FREMONT BLVD.
FREMONT, CA US
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Contact CHARLES L ROSE
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 02/16/1993
Decision Date 05/21/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee DE - Dental
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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