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FDA 510(k) Application Details - K081774
Device Classification Name
Laser, Ophthalmic
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510(K) Number
K081774
Device Name
Laser, Ophthalmic
Applicant
SOLX INC.
890 WINTER ST., SUITE 115
WALTHAM, MA 02451 US
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DOUG ADAMS
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Regulation Number
886.4390
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Classification Product Code
HQF
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Date Received
06/23/2008
Decision Date
09/12/2008
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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