Name: Predicase
Price: 199 USD

K-number	K182873
Device name	STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
Applicant	ETHICON, Inc.
Product code	NEW
Device class	Class II
Decision date	Jan 10, 2019
Decision	Substantially Equivalent
Regulation	878.4840

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Source

View the full FDA submission: accessdata.fda.gov

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STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices

Everything you need for a 510(k) submission. Nothing you don't.