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

TRITON HUDSON CHUCK ATTACHMENT

K Number: K983092 · Decision Nov 6, 1998
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
26
Applicant Total
7
Review Days
64

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Basic Information

Device Name
TRITON HUDSON CHUCK ATTACHMENT
K Number
K983092
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.4370
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Mednext, Inc.
Date Received
September 3, 1998
Decision Date
November 6, 1998
Product Code
HBB
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

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

Product Code Device Name
HBB Motor, Drill, Pneumatic

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Other Clearances by Mednext, Inc.

K Number Device Name
K972308 MEDNEXT 1000 DRILL
K970023 MEDNEXT SURGICAL BUR
K943108 MEDNEXT MICRO-DRILL
K935861 MEDNEXT BUR
K935584 MEDNEXT BUR
K926547 MEDNEXT 1000 BONE DISSECTING SYSTEM