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

DW234 #29

K Number: K941625 · Decision Jun 22, 1994
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
10
Review Days
79

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Basic Information

Device Name
DW234 #29
K Number
K941625
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3060
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Rms Div.
Date Received
April 4, 1994
Decision Date
June 22, 1994
Product Code
EJS
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

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

Product Code Device Name
EJS Alloy, Other Noble Metal

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K944557 DW250 #91
K902403 ELITE R/F SPOT FILM DRIVE
K902146 SFD-035 SPOT FILM DEVICE
K896665 EXT-600 TABLE, RADIOGRAPHIC, ELEVATING
K896119 RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE
K896324 ELITE 1500 RADIOGRAPHIC TILTING TABLE