510(k) K832481

SCLERAL BUCKLING IMPLANTS DIF/TYPES by Storz Instrument Co. — Product Code HQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
July 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Orbital, Extra-Ocular
Device Class
Class II
Regulation Number
886.3340
Review Panel
OP
Submission Type