SPIROCARE 108-B— 510(k) K782016

Substantially Equivalent

Marion Laboratories, Inc.

FDA 510(k) clearance K782016 for SPIROCARE 108-B, Substantially Equivalent on 1978-12-13. Applicant: Marion Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Marion Laboratories, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1978-12-05
Decision date: 1978-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.