ENDO SMARTCAP (100501)— 510(k) K971125

Substantially Equivalent

Endo Smart Cap Co.

FDA 510(k) clearance K971125 for ENDO SMARTCAP (100501), Substantially Equivalent on 1997-05-23. Applicant: Endo Smart Cap Co.. Device class: 2.

Clearance details

Applicant: Endo Smart Cap Co.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1997-03-27
Decision date: 1997-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.