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510(k) K220257

Permadyne by 3M Deutschland GmbH — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2022
Date Received
January 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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