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FDA 510(k) Application Details - K001964
Device Classification Name
Products, Contact Lens Care, Rigid Gas Permeable
More FDA Info for this Device
510(K) Number
K001964
Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Applicant
LOBOB LABORATORIES, INC.
2000 M ST. NW # 700
WASHINGTON, DC 20036-3307 US
Other 510(k) Applications for this Company
Contact
DANIEL J MANELLI
Other 510(k) Applications for this Contact
Regulation Number
886.5918
More FDA Info for this Regulation Number
Classification Product Code
MRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/2000
Decision Date
07/18/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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