SPECULUM— 510(k) K933521

Substantially Equivalent

Bioteque America, Inc.

FDA 510(k) clearance K933521 for SPECULUM, Substantially Equivalent on 1994-03-07. Applicant: Bioteque America, Inc.. Device class: 2.

Clearance details

Applicant: Bioteque America, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1993-07-20
Decision date: 1994-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, 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.