FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE TELOS EQUIPMENT
K Number: K812778
·
Decision Dec 8, 1981
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
12
Applicant Total
2
Review Days
64
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Basic Information
- Device Name
- THE TELOS EQUIPMENT
- K Number
- K812778
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1520
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- The Telos Co.
- Date Received
- October 5, 1981
- Decision Date
- December 8, 1981
- Product Code
- KQW
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KQW | Goniometer, Nonpowered | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KQW), ordered by most recent decision date.
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DOBBHOFF(R) RETRIEVAL FORCEPS
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UNIVERSAL GONIMETER
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Other Clearances by The Telos Co.
| K Number | Device Name | ||
|---|---|---|---|
| K812779 | EXTENSIONS-LUSATZTISCH | Oct 26, 1981 | Substantially Equivalent |