FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE

K Number: K060623 · Decision Sep 6, 2006
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
26
Applicant Total
32
Review Days
182

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Basic Information

Device Name
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
K Number
K060623
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Cook Ireland, Ltd.
Date Received
March 8, 2006
Decision Date
September 6, 2006
Product Code
FER
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FER Anoscope And Accessories

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