510(k) K022723

MASTEL 1 FOLDER IMPLANTATION SYSTEM by Mastel Precision, Inc. — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2002
Date Received
August 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type