FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

ANU-RX

K Number: K862490 · Decision Aug 18, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
17
Applicant Total
2
Review Days
48

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Basic Information

Device Name
ANU-RX
K Number
K862490
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
J. & Jp., Inc.
Date Received
July 1, 1986
Decision Date
August 18, 1986
Product Code
LKX
Advisory Committee
Unknown
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
LKX Device, Thermal, Hemorrhoids

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Other Clearances by J. & Jp., Inc.

K Number Device Name
K852679 MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE