FDA 510(k) Application Details - K980784

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K980784
Device Name Powered Laser Surgical Instrument
Applicant SAHAR TECHNOLOGIES, INC.
3940 RUFFIN RD., SUITE C
SAN DIEGO, CA 92123 US
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Contact GARY SHAFFER
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 03/02/1998
Decision Date 04/29/1998
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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