RESPA-TROL— 510(k) K810107

Substantially Equivalent

Intensive Technology, Inc.

FDA 510(k) clearance K810107 for RESPA-TROL, Substantially Equivalent on 1981-01-26. Applicant: Intensive Technology, Inc.. Device class: 1.

Clearance details

Applicant: Intensive Technology, Inc.
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1981-01-16
Decision date: 1981-01-26
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.