Name: Predicase
Price: 199 USD

K-number	K172659
Device name	MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
Applicant	M/s. Meril Endo Surgery Private Limited.
Product code	GAM
Device class	Class II
Decision date	Sep 28, 2017
Decision	Substantially Equivalent
Regulation	878.4493

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View the full FDA submission: accessdata.fda.gov

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MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture

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