ROCAMED ROCAUS PLATINUM— 510(k) K120160

Substantially Equivalent

Promepla Sam

FDA 510(k) clearance K120160 for ROCAMED ROCAUS PLATINUM, Substantially Equivalent on 2012-05-14. Applicant: Promepla Sam.

Clearance details

Applicant: Promepla Sam
Product code: Code KNY
Advisory panel: Gastroenterology, Urology
Date received: 2012-01-19
Decision date: 2012-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monaco, MC

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