DELTA-ROL— 510(k) K790340

Name: FDA 510(k) clearance K790340
Creator: U.S. Food and Drug Administration
Published: 1979-04-12

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K790340 for DELTA-ROL, Substantially Equivalent on 1979-04-12. Applicant: Johnson & Johnson Professionals, Inc.. Device class: 2.

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code GCO
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1979-02-21
Decision date: 1979-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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