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510(k) K220219

PERMALOOP Suture, PERMATAPE Suture by Medos International SARL — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2022
Date Received
January 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

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