DIA-SPEC— 510(k) K822086

Substantially Equivalent

Exitec, Inc.

FDA 510(k) clearance K822086 for DIA-SPEC, Substantially Equivalent on 1982-11-08. Applicant: Exitec, Inc.. Device class: 2.

Clearance details

Applicant: Exitec, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1982-07-13
Decision date: 1982-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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