Atlas FDA

ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E

FDA 510(k) clearance K022821 · decided 2002-11-15

Clearance details

K-number
K022821
Device name
ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E
Applicant
Ideatrics, Inc.
Decision
Substantially Equivalent
Date received
2002-08-26
Decision date
2002-11-15
Days to decision
81 days
Clearance type
Traditional
Product code
DZK
Device class
2
Regulation number
872.4880
Medical specialty
Dental
Advisory committee
Dental
Location
Boulder, CO, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

No recalls on record reference this clearance.