PREG-TEX— 510(k) K790898

Substantially Equivalent

Biologics Intl., Inc.

FDA 510(k) clearance K790898 for PREG-TEX, Substantially Equivalent on 1979-07-30. Applicant: Biologics Intl., Inc.. Device class: 2.

Clearance details

Applicant: Biologics Intl., Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1979-05-09
Decision date: 1979-07-30
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.