Home / 510(k) Clearances / K150717

510(k) K150717

Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron by M/s. Meril Endo Surgery Private Limited. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2015
Date Received
March 19, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

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  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
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