DISPOSABLE COUPLING ADAPTOR— 510(k) K801261

Name: FDA 510(k) clearance K801261
Creator: U.S. Food and Drug Administration
Published: 1980-06-09

Substantially Equivalent

Intec Medical, Inc.

FDA 510(k) clearance K801261 for DISPOSABLE COUPLING ADAPTOR, Substantially Equivalent on 1980-06-09. Applicant: Intec Medical, Inc.. Device class: 1.

Clearance details

Applicant: Intec Medical, Inc.
Product code: Code BYX
Device class: Class 1
Regulation: 21 CFR 868.5860
Advisory panel: Anesthesiology
Date received: 1980-05-28
Decision date: 1980-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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