TOBRAM E.R.A. TM— 510(k) K800517

Substantially Equivalent

P-L Biochemicals, Inc.

FDA 510(k) clearance K800517 for TOBRAM E.R.A. TM, Substantially Equivalent on 1980-03-20. Applicant: P-L Biochemicals, Inc.. Device class: 2.

Clearance details

Applicant: P-L Biochemicals, Inc.
Product code: Code KLQ
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 1980-03-05
Decision date: 1980-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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