FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESOUND IMPRESSION MATERIAL
K Number: K892935
·
Decision Jul 14, 1989
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
41
Review Days
84
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Basic Information
- Device Name
- RESOUND IMPRESSION MATERIAL
- K Number
- K892935
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Resound Corp.
- Date Received
- April 21, 1989
- Decision Date
- July 14, 1989
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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|---|---|---|---|
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| K970215 | AUDALLION II HEARING SYSTEM | Mar 31, 1997 | Substantially Equivalent |
| K964557 | RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | Nov 27, 1996 | Substantially Equivalent |
| K964115 | RESOUND CC4 PERSONAL HEARING SYSTEM | Nov 4, 1996 | Substantially Equivalent |
| K960684 | HEARING AID - AIR CONDUCTION | Apr 10, 1996 | Substantially Equivalent |
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