MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT


Device Classification Name

implant, eye sphere

510(k) Number K021357
Device Name MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
Original Applicant
POREX SURGICAL, INC.
15 dart rd.
newnan, 
GA 
30265

Original Contact howard mercer
Regulation Number 886.3320
Classification Product Code
HPZ  
Date Received 04/29/2002
Decision Date 08/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls