INAMED RHEMO-D (TM) DILATOR— 510(k) K894618

Name: FDA 510(k) clearance K894618
Creator: U.S. Food and Drug Administration
Published: 1990-01-18

Substantially Equivalent

Inamed Development Co.

FDA 510(k) clearance K894618 for INAMED RHEMO-D (TM) DILATOR, Substantially Equivalent on 1990-01-18. Applicant: Inamed Development Co.. Device class: 1.

Clearance details

Applicant: Inamed Development Co.
Product code: Code FFP
Device class: Class 1
Regulation: 21 CFR 876.5450
Advisory panel: Gastroenterology, Urology
Date received: 1989-07-20
Decision date: 1990-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, 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.