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FDA 510(k) Application Details - K091534
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K091534
Device Name
Laser, Ophthalmic
Applicant
LIGHTMED CORP.
NO.1-1, LANE1,PAO-AN ST. SEC.3
SHULIN CITY
TAIPEI 238 TW
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Contact
ANITA CHEN
Other 510(k) Applications for this Contact
Regulation Number
886.4390
More FDA Info for this Regulation Number
Classification Product Code
HQF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/26/2009
Decision Date
09/18/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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