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FDA 510(k) Application Details - K982556
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K982556
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
RADIOTHERAPEUTICS CORP.
2685 MARINE WAY, SUITE 1408
MOUNTAIN VIEW, CA 94043 US
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Contact
COLIN J NICHOLS
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Regulation Number
878.4400
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Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
07/22/1998
Decision Date
04/06/2000
Decision
SESU - SE - WITH LIMITATIONS
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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