SERIM HISENSE ULTRA 0.1, PART NUMBER 5167— 510(k) K080712

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K080712 for SERIM HISENSE ULTRA 0.1, PART NUMBER 5167, Substantially Equivalent on 2008-05-06. Applicant: Serim Research Corp..

Clearance details

Applicant: Serim Research Corp.
Product code: Code MSY
Advisory panel: Gastroenterology, Urology
Date received: 2008-03-13
Decision date: 2008-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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