BIOPSY DEVICE ACCESSORY— 510(k) K944252

Substantially Equivalent

Biopsys Medical, Inc.

FDA 510(k) clearance K944252 for BIOPSY DEVICE ACCESSORY, Substantially Equivalent on 1994-12-05. Applicant: Biopsys Medical, Inc.. Device class: 2.

Clearance details

Applicant: Biopsys Medical, Inc.
Product code: Code FCK
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1994-08-30
Decision date: 1994-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.