510(k) K941550

AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT by Chiron Vision Corp. — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
March 30, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type