FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

PANAMEX(TM) URETERAL STENT

K Number: K882157 · Decision Aug 2, 1988
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
6
Review Days
71

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Basic Information

Device Name
PANAMEX(TM) URETERAL STENT
K Number
K882157
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.4620
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Applicant
Kingston Technologies, Inc.
Date Received
May 23, 1988
Decision Date
August 2, 1988
Product Code
FAD
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
FAD Stent, Ureteral

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K940738 KTI HY-Q(TM) WOUND DRESSING
K925660 KTI TRANSPARENT WOUND DRESSING
K921502 HYSORB WOUND DRESSING