FDA 510(k) Application Details - K992446

Device Classification Name Lens, Contact, (Disposable)

  More FDA Info for this Device
510(K) Number K992446
Device Name Lens, Contact, (Disposable)
Applicant CIBA VISION JOHNS CREEK MFG.
11460 JOHNS CREEK PKWY.
DULUTH, GA 30097 US
Other 510(k) Applications for this Company
Contact ALICIA M PLESNARSKI
Other 510(k) Applications for this Contact
Regulation Number 886.5925

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

  More FDA Info for this Product Code
Date Received 07/22/1999
Decision Date 08/18/1999
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