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FDA 510(k) Application Details - K020304
Device Classification Name
Light, Surgical, Accessories
More FDA Info for this Device
510(K) Number
K020304
Device Name
Light, Surgical, Accessories
Applicant
ASPEN SURGICAL PRODUCTS, INC.
7425 CLYDE PARK, SUITE G
GRAND RAPIDS, MI 49315-0404 US
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Contact
ROY MELLING
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
FTA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/29/2002
Decision Date
02/14/2002
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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