FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROBINSON MIDDLE EAR PROSTHESIS
K Number: K760570
·
Decision Sep 21, 1976
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
3
Applicant Total
82
Review Days
20
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Basic Information
- Device Name
- ROBINSON MIDDLE EAR PROSTHESIS
- K Number
- K760570
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Xomed, Inc.
- Date Received
- September 1, 1976
- Decision Date
- September 21, 1976
- Product Code
- EIB
- 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 |
|---|---|---|---|
| EIB | Syringe, Irrigating (Dental) | FDA class 1 | Dental |
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| K993582 | MODIFICATION TO LASER-SHIELD II | Jan 20, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |