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510(k) K231822

GOLFF Sterile Anti-Fog Solution by Batrik Medical Manufacturing, Inc. — Product Code OCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2024
Date Received
June 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

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