ENTEROTUBE II— 510(k) K781236

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K781236 for ENTEROTUBE II, Substantially Equivalent on 1978-08-31. Applicant: Hoffmann-La Roche, Inc.. Device class: 1.

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code JSS
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1978-07-20
Decision date: 1978-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, 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.