FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

VERESS CANNULA AND MODULAR VERESS CANNULA

K Number: K062097 · Decision Oct 13, 2006
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
44
Review Days
81

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Basic Information

Device Name
VERESS CANNULA AND MODULAR VERESS CANNULA
K Number
K062097
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
884.1720
Medical Specialty
Obstetrics/Gynecology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
PAJUNK GmbH Medizintechnologie
Date Received
July 24, 2006
Decision Date
October 13, 2006
Product Code
HET
Advisory Committee
Obstetrics/Gynecology
Review Advisory Committee
OB
Third Party
N

Classifications

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

Product Code Device Name
HET Laparoscope, Gynecologic (And Accessories)

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