PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117— 510(k) K050112

Name: FDA 510(k) clearance K050112
Creator: U.S. Food and Drug Administration
Published: 2005-03-15

Substantially Equivalent

Prime Pacific Health Innovations Corporation

FDA 510(k) clearance K050112 for PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117, Substantially Equivalent on 2005-03-15. Applicant: Prime Pacific Health Innovations Corporation. Device class: 2.

Clearance details

Applicant: Prime Pacific Health Innovations Corporation
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 2005-01-18
Decision date: 2005-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Vancouver, Bc, CA

Download summary PDF View on FDA.gov ↗

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