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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact