A,SA2 LYOPHILIZED HEMO CONTROL— 510(k) K800853

Name: FDA 510(k) clearance K800853
Creator: U.S. Food and Drug Administration
Published: 1980-04-29

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K800853 for A,SA2 LYOPHILIZED HEMO CONTROL, Substantially Equivalent on 1980-04-29. Applicant: Helena Laboratories. Device class: 2.

Clearance details

Applicant: Helena Laboratories
Product code: Code JBD
Device class: Class 2
Regulation: 21 CFR 864.7440
Advisory panel: Hematology
Date received: 1980-04-15
Decision date: 1980-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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