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FDA 510(k) Application Details - K960380
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K960380
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
UNILENS CORP., USA
10431 72ND ST. NORTH
P.O. BOX 2530
LARGO, FL 34647 US
Other 510(k) Applications for this Company
Contact
JOSEPHA BRUNO
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
01/26/1996
Decision Date
03/28/1996
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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