SCANLAN STERNUM NEEDLE-SUTURE— 510(k) K801976

Name: FDA 510(k) clearance K801976
Creator: U.S. Food and Drug Administration
Published: 1980-09-26

Substantially Equivalent

Scanlan Intl., Inc.

FDA 510(k) clearance K801976 for SCANLAN STERNUM NEEDLE-SUTURE, Substantially Equivalent on 1980-09-26. Applicant: Scanlan Intl., Inc.. Device class: 1.

Clearance details

Applicant: Scanlan Intl., Inc.
Product code: Code GAB
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1980-08-19
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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