510(k) K022982

MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB by Med-Logics, Inc. — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2002
Date Received
September 9, 2002
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