FDA 510(k) Application Details - K983836

Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable

  More FDA Info for this Device
510(K) Number K983836
Device Name Products, Contact Lens Care, Rigid Gas Permeable
Applicant POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14692 US
Other 510(k) Applications for this Company
Contact DEBRA L.B. KETCHUM
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 10/30/1998
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



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