510(k) K022637

BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME by Becton, Dickinson & CO — Product Code HMY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2002
Date Received
August 8, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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