MASTEL 1 FOLDER IMPLANTATION SYSTEM


Device Classification Name

lens, guide, intraocular

510(k) Number K022723
Device Name MASTEL 1 FOLDER IMPLANTATION SYSTEM
Original Applicant
MASTEL PRECISION, INC.
53 barcelona
irvine, 
CA 
92614

Original Contact maureen weiner
Regulation Number 886.4300
Classification Product Code
KYB  
Date Received 08/16/2002
Decision Date 12/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No