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510(k) K941660

GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT by Gm Engineering, Inc. — Product Code KYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1994
Date Received
April 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Ophthalmic
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

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