Name: Predicase
Price: 199 USD

K-number	K991630
Device name	ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET
Applicant	Advanced Medical Solutions Group Plc
Product code	MDA
Device class	Class I
Decision date	Jun 11, 1999
Decision	Substantially Equivalent
Regulation	878.4025

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Source

View the full FDA submission: accessdata.fda.gov

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ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET

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