FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED DIAMOND BURS
K Number: K041978
·
Decision Nov 23, 2004
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
36
Review Days
123
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Basic Information
- Device Name
- REPROCESSED DIAMOND BURS
- K Number
- K041978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alliance Medical Corp.
- Date Received
- July 23, 2004
- Decision Date
- November 23, 2004
- Product Code
- NLN
- 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 | Device Class | Medical Specialty |
|---|---|---|---|
| NLN | Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed | FDA class 2 | Neurology |
Other Clearances by Alliance Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K060648 | REPROCESSED PHACOEMULSIFICATION TIPS | Mar 19, 2007 | Substantially Equivalent |
| K061045 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Aug 31, 2006 | Substantially Equivalent |
| K060049 | REPROCESSED COMPRESSION SLEEVES | Feb 24, 2006 | Substantially Equivalent |
| K060091 | ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES | Feb 17, 2006 | Substantially Equivalent |
| K053316 | REPROCESSED COMPRESSION SLEEVES | Feb 13, 2006 | Substantially Equivalent |
| K052918 | REPROCESSED EXTERNAL FIXATION DEVICES | Jan 27, 2006 | Substantially Equivalent |
| K052603 | REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS | Nov 16, 2005 | Substantially Equivalent |
| K052414 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Nov 16, 2005 | Substantially Equivalent |
| K052064 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | Aug 25, 2005 | Substantially Equivalent |
| K052062 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | Aug 25, 2005 | Substantially Equivalent |