STERI-LUB LUBRICATION GEL— 510(k) K944969

Name: FDA 510(k) clearance K944969
Creator: U.S. Food and Drug Administration
Published: 1995-02-27

Substantially Equivalent

Horizon Medical, Inc.

FDA 510(k) clearance K944969 for STERI-LUB LUBRICATION GEL, Substantially Equivalent on 1995-02-27. Applicant: Horizon Medical, Inc.. Device class: 1.

Clearance details

Applicant: Horizon Medical, Inc.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 1994-10-11
Decision date: 1995-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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