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FDA 510(k) Application Details - K982774
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K982774
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
CL-TINTERS
HOYLAAMOTIE 7
HELSINKI 00380 FI
Other 510(k) Applications for this Company
Contact
MARTIN S KROPF
Other 510(k) Applications for this Contact
Regulation Number
886.5925
More FDA Info for this Regulation Number
Classification Product Code
LPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/07/1998
Decision Date
09/02/1998
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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