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FDA 510(k) Application Details - K111856
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K111856
Device Name
Case, Contact Lens
Applicant
APOTHECARY PRODUCTS, INC.
11750 12TH AVE. SOUTH
BURNSVILLE, MN 55337 US
Other 510(k) Applications for this Company
Contact
JAMES JENKINS
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
06/29/2011
Decision Date
07/14/2011
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
Y
Expedited Review
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