ISOLATE— 510(k) K971809

Substantially Equivalent

Irvine Scientific Sales Co., Inc.

FDA 510(k) clearance K971809 for ISOLATE, Substantially Equivalent on 1997-07-03. Applicant: Irvine Scientific Sales Co., Inc..

Clearance details

Applicant: Irvine Scientific Sales Co., Inc.
Product code: Code MQL
Advisory panel: Obstetrics/Gynecology
Date received: 1997-05-15
Decision date: 1997-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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