LUBRIGLIDE— 510(k) K973557

Substantially Equivalent

Qualis, Inc.

FDA 510(k) clearance K973557 for LUBRIGLIDE, Substantially Equivalent on 1997-10-10. Applicant: Qualis, Inc.. Device class: 1.

Clearance details

Applicant: Qualis, Inc.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 1997-09-19
Decision date: 1997-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Moines, IA, US

Download summary PDF View on FDA.gov ↗

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K973780 — PERSONAL LUBRICATING LIQUID1997-11-26

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