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FDA 510(k) Application Details - K102857
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
More FDA Info for this Device
510(K) Number
K102857
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
AHWON MEDI INSTRUMENT CO., LTD
111 ELLISON STREET
PATERSON, NJ 07505 US
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Contact
YOUNG CHI
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
ONF
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More FDA Info for this Product Code
Date Received
09/29/2010
Decision Date
01/14/2011
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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