FDA 510(k) Application Details - K994428

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K994428
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC.
5920 LONGBOW DR.
P.O. BOX 9015
BOULDER, CO 80301 US
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Contact ROBERT C MOORE JR
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 12/30/1999
Decision Date 03/07/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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