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FDA 510(k) Application Details - K990044
Device Classification Name
Accessories, Soft Lens Products
More FDA Info for this Device
510(K) Number
K990044
Device Name
Accessories, Soft Lens Products
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
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LPN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/1999
Decision Date
02/11/1999
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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