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510(k) K232968

Grande Medical Masks, Model SF-600 by Golden Grande Corp. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2024
Date Received
September 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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