FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINNE TIES MMF Suture System
K Number: K162046
·
Decision Apr 11, 2017
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
9
Review Days
260
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Basic Information
- Device Name
- MINNE TIES MMF Suture System
- K Number
- K162046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4600
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Summit Medical, Inc.
- Date Received
- July 25, 2016
- Decision Date
- April 11, 2017
- Product Code
- DYX
- 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 | Device Class | Medical Specialty |
|---|---|---|---|
| DYX | Lock, Wire, And Ligature, Intraoral | FDA class 2 | Dental |
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| K142630 | Instru-Safe Instrument Protection System | Dec 23, 2014 | Substantially Equivalent |
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| K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Jun 27, 2014 | Substantially Equivalent |
| K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | Mar 13, 2014 | Substantially Equivalent |