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FDA 510(k) Application Details - K974281
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K974281
Device Name
Case, Contact Lens
Applicant
ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH, TX 76134-2099 US
Other 510(k) Applications for this Company
Contact
RALPH H LARSEN
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/1997
Decision Date
01/20/1998
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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