FDA 510(k) Application Details - K022723

Device Classification Name Lens, Guide, Intraocular

  More FDA Info for this Device
510(K) Number K022723
Device Name Lens, Guide, Intraocular
Applicant MASTEL PRECISION, INC.
53 BARCELONA
IRVINE, CA 92614 US
Other 510(k) Applications for this Company
Contact MAUREEN WEINER
Other 510(k) Applications for this Contact
Regulation Number 886.4300

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

  More FDA Info for this Product Code
Date Received 08/16/2002
Decision Date 12/26/2002
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