FDA 510(k) Application Details - K023481

Device Classification Name Implant, Orbital, Extra-Ocular

  More FDA Info for this Device
510(K) Number K023481
Device Name Implant, Orbital, Extra-Ocular
Applicant MICROVISION, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact SHEILA HEMEON-HEYER, JD, RAC
Other 510(k) Applications for this Contact
Regulation Number 886.3340

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

  More FDA Info for this Product Code
Date Received 10/17/2002
Decision Date 01/08/2003
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