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FDA 510(k) Application Details - K991995
Device Classification Name
System,In-Office Tinting,Contact Lenses
More FDA Info for this Device
510(K) Number
K991995
Device Name
System,In-Office Tinting,Contact Lenses
Applicant
SOFTCHROME, INC.
623 GLACIER DR.
GRAND JUNCTION, CO 81503 US
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Contact
MARTIN DALSING
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Regulation Number
886.5925
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Classification Product Code
MZD
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More FDA Info for this Product Code
Date Received
06/14/1999
Decision Date
08/27/1999
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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