Name: Predicase
Price: 199 USD

K-number	K182079
Device name	Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
Applicant	Medtec Inc. Dba Civco Medical Solutions
Product code	IYE
Device class	Class II
Decision date	Sep 7, 2018
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask

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