SANDHILL AMS— 510(k) K863312

Substantially Equivalent

Sandhill

FDA 510(k) clearance K863312 for SANDHILL AMS, Substantially Equivalent on 1986-12-03. Applicant: Sandhill. Device class: 2.

Clearance details

Applicant
Sandhill
Product code
Code FAP
Device class
Class 2
Regulation
21 CFR 876.1620
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Burbank, CA, US
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