FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SECUTEX WRIST BRACE
K Number: K791249
·
Decision Jul 24, 1979
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
51
Applicant Total
122
Review Days
18
Basic Information
- Device Name
- SECUTEX WRIST BRACE
- K Number
- K791249
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- CONPHAR, INC.
- Date Received
- July 6, 1979
- Decision Date
- July 24, 1979
- Product Code
- IQI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IQI | Orthosis, Limb Brace | FDA class 1 | Physical Medicine |
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Other Clearances by CONPHAR, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K821825 | CONPHAR SILICONE FEEDING TUBE | Aug 10, 1982 | Substantially Equivalent |
| K821289 | MAYO-HEGAR NEEDLE HOLDER | Jun 3, 1982 | Substantially Equivalent |
| K821295 | OLSEN HEGAR NEEDLE HOLDERS | Jun 3, 1982 | Substantially Equivalent |
| K821354 | CONPHAR MAYO HEGAR NEEDLE HOLDER | Jun 3, 1982 | Substantially Equivalent |
| K821275 | MAYO SCISSOR STRAIGHT 5 1/2 | May 28, 1982 | Substantially Equivalent |
| K821276 | MAYO SCISSOR CURYED 5 1/2 | May 28, 1982 | Substantially Equivalent |
| K821273 | MAYO SCISSOR STRAIGHT 6 3/4 | May 28, 1982 | Substantially Equivalent |
| K821285 | SPLINTER FORCEPS 4 1/2 | May 28, 1982 | Substantially Equivalent |
| K821284 | ADSON FORCEPS 4 3/4 | May 28, 1982 | Substantially Equivalent |
| K821292 | TONSIL SCISSORS 7 | May 28, 1982 | Substantially Equivalent |