FDA 510(k) Application Details - K961133

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K961133
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant SOMNUS MEDICAL TECHNOLOGIES, INC.
21070 HOMESTEAD RD.
CUPERTINO, CA 94043 US
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Contact THOMAS C WEHMAN
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 03/21/1996
Decision Date 07/10/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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