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510(k) K240438

CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) by Comercializadora Brever — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2024
Date Received
February 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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