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FDA 510(k) Application Details - K955834
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K955834
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
ASPEN LABORATORIES, INC.
14603 E. FREMONT AVE.
ENGLEWOOD, CO 80112 US
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Contact
CHARLES M HART
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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
12/26/1995
Decision Date
07/11/1996
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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