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510(k) K192953

APTOS Threads – Polypropylene Surgical Sutures by Aptos, LLC — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2020
Date Received
October 21, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

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