FDA 510(k) Application Details - K970698

Device Classification Name Lens, Contact (Other Material) - Daily

  More FDA Info for this Device
510(K) Number K970698
Device Name Lens, Contact (Other Material) - Daily
Applicant POLYMER TECHNOLOGY CORP.
1400 N. GOODMAN ST.
ROCHESTER, NY 14692 US
Other 510(k) Applications for this Company
Contact DOUGLAS J FORTUNATO
Other 510(k) Applications for this Contact
Regulation Number 886.5916

  More FDA Info for this Regulation Number
Classification Product Code HQD
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 02/25/1997
Decision Date 05/06/1997
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