510(k) K942180

KEELER MULTILASE 3000 by Keeler Instruments, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
May 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type