SCANLAN TUNNELER, SHEATH & TIP— 510(k) K851825

Name: FDA 510(k) clearance K851825
Creator: U.S. Food and Drug Administration
Published: 1985-07-12

Substantially Equivalent

Scanlan Intl., Inc.

FDA 510(k) clearance K851825 for SCANLAN TUNNELER, SHEATH & TIP, Substantially Equivalent on 1985-07-12. Applicant: Scanlan Intl., Inc.. Device class: 1.

Clearance details

Applicant: Scanlan Intl., Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1985-04-26
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

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