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FDA 510(k) Application Details - K033933
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K033933
Device Name
Powered Laser Surgical Instrument
Applicant
PRESWEDE AB
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
Other 510(k) Applications for this Company
Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
12/19/2003
Decision Date
03/16/2004
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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