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510(k) K241123

Perpak™ Sterilization Tyvek Pouch by Km Corp. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2024
Date Received
April 23, 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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