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510(k) K895908

MULES SPHERE GLASS (SEVERAL SIZES) by Ginsberg Scientific, Inc. — Product Code HPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1990
Date Received
October 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Sphere
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

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