OPHTEC ENCLAVATION NEEDLE


Device Classification Name

hook, ophthalmic

510(k) Number K030471
Device Name OPHTEC ENCLAVATION NEEDLE
Applicant
OPHTEC USA
6421 congress ave. ste 112
boca raton, 
FL 
33487

Applicant Contact rick mccarley
Correspondent
OPHTEC USA
6421 congress ave. ste 112
boca raton, 
FL 
33487

Correspodent Contact rick mccarley
Regulation Number 886.4350
Classification Product Code
HNQ  
Date Received 02/12/2003
Decision Date 04/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No