FDA 510(k)
Substantially Equivalent
🇺🇸 United States
STONE, INSTRUMENT HONING
K Number: K844379
·
Decision Nov 29, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
80
Review Days
16
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Basic Information
- Device Name
- STONE, INSTRUMENT HONING
- K Number
- K844379
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Treace Medical, Inc.
- Date Received
- November 13, 1984
- Decision Date
- November 29, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Treace Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883727 | BUCKET PROSTHESIS PORP | Jan 13, 1989 | Substantially Equivalent |
| K882349 | MALLET, SURGICAL | Jun 23, 1988 | Substantially Equivalent |
| K874779 | BIPOLATOR 50 | Jan 29, 1988 | Substantially Equivalent |
| K873154 | TREACE MAGNUM OTO-TOOL SYSTEM | Sep 4, 1987 | Substantially Equivalent |
| K872000 | EYE GARD | Jul 21, 1987 | Substantially Equivalent |
| K870765 | CANNULATED INSTRUMENT CLEANERS | May 27, 1987 | Substantially Equivalent |
| K871706 | OPTHA PREP | May 18, 1987 | Substantially Equivalent |
| K870759 | CLEANING SOLUTION, CATALOG NO. 8203 | May 7, 1987 | Substantially Equivalent |
| K870766 | PROSTHESIS WIRE | Apr 15, 1987 | Substantially Equivalent |
| K870760 | BUR BRUSH | Mar 18, 1987 | Substantially Equivalent |