SIGMOIDOSCOPE, FLEXIBLE— 510(k) K822765

Substantially Equivalent

Harvard Laboratories

FDA 510(k) clearance K822765 for SIGMOIDOSCOPE, FLEXIBLE, Substantially Equivalent on 1982-11-17. Applicant: Harvard Laboratories. Device class: 2.

Clearance details

Applicant
Harvard Laboratories
Product code
Code FAM
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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