SANDHILL DMS— 510(k) K821588

Substantially Equivalent

Sandhill

FDA 510(k) clearance K821588 for SANDHILL DMS, Substantially Equivalent on 1982-06-22. Applicant: Sandhill. Device class: 2.

Clearance details

Applicant
Sandhill
Product code
Code KLA
Device class
Class 2
Regulation
21 CFR 876.1725
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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