BSI MODEL TIP— 510(k) K897191

Substantially Equivalent

Bales Scientific, Inc.

FDA 510(k) clearance K897191 for BSI MODEL TIP, Substantially Equivalent on 1990-07-13. Applicant: Bales Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Bales Scientific, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1989-12-28
Decision date: 1990-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, 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.