FDA 510(k) Application Details - K981574

Device Classification Name Accessories, Soft Lens Products

  More FDA Info for this Device
510(K) Number K981574
Device Name Accessories, Soft Lens Products
Applicant ALCON
6201 SOUTH FREEWAY
FORT WORTH, TX 76134-2099 US
Other 510(k) Applications for this Company
Contact MICHAEL PFLEGER
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 05/04/1998
Decision Date 07/06/1998
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



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