FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MATRICS
K Number: K904756
·
Decision Mar 15, 1991
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
32
Review Days
147
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Basic Information
- Device Name
- MATRICS
- K Number
- K904756
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kerr Corporation (Danbury)
- Date Received
- October 19, 1990
- Decision Date
- March 15, 1991
- Product Code
- ESD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
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|---|---|---|---|
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| K951663 | TYTIN R | Jun 6, 1995 | Substantially Equivalent |
| K951511 | TYTIN ADMIX | May 2, 1995 | Substantially Equivalent |
| K942480 | M4 CONTRA-ANGLE HANDPIECE | Jan 27, 1995 | Substantially Equivalent |
| K940513 | OPTIBOND | Apr 15, 1994 | Substantially Equivalent |
| K935535 | TYTIN | Mar 11, 1994 | Substantially Equivalent |
| K934690 | KERR OPTIBOND, MODIFICATION | Dec 30, 1993 | Substantially Equivalent |
| K923546 | OPTIBOND | Sep 29, 1992 | Substantially Equivalent |
| K915847 | AUTOMIX DENTAL AMALGAMATOR | Mar 2, 1992 | Substantially Equivalent |