ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA— 510(k) K964561

Name: FDA 510(k) clearance K964561
Creator: U.S. Food and Drug Administration
Published: 1997-02-11

Substantially Equivalent

Bioenterics Corp.

FDA 510(k) clearance K964561 for ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA, Substantially Equivalent on 1997-02-11. Applicant: Bioenterics Corp.. Device class: 1.

Clearance details

Applicant: Bioenterics Corp.
Product code: Code FDG
Device class: Class 1
Regulation: 21 CFR 876.4530
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-13
Decision date: 1997-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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