CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR


Device Classification Name

lens, contact, (disposable)

510(k) Number K073060
Device Name CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Applicant
INNOVA VISION INC.
2904 n. boldt drive
flaggstaff, 
AZ 
86001

Applicant Contact jennifer reich
Correspondent
INNOVA VISION INC.
2904 n. boldt drive
flaggstaff, 
AZ 
86001

Correspodent Contact jennifer reich
Regulation Number 886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received 10/30/2007
Decision Date 11/29/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No