FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECNOL BUCKS TRACTION W/HEEL PROTECTOR
K Number: K884132
·
Decision Oct 11, 1988
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
10
Applicant Total
2
Review Days
11
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Basic Information
- Device Name
- TECNOL BUCKS TRACTION W/HEEL PROTECTOR
- K Number
- K884132
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5890
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Technol, Inc.
- Date Received
- September 30, 1988
- Decision Date
- October 11, 1988
- Product Code
- KQZ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KQZ | Component, Traction, Non-Invasive | FDA class 1 | Orthopedic |
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Other Clearances by Technol, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861528 | TECNOL PERSONAL SHOE COVER | May 12, 1986 | Substantially Equivalent |