FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAPP TERMINAL DEVICE
K Number: K780890
·
Decision Jun 13, 1978
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
0
Applicant Total
9
Review Days
13
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Basic Information
- Device Name
- CAPP TERMINAL DEVICE
- K Number
- K780890
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3420
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Hosmer Dorrance Corp.
- Date Received
- May 31, 1978
- Decision Date
- June 13, 1978
- Product Code
- IQX
- 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 |
|---|---|---|---|
| IQX | Hook, External Limb Component, Mechanical | FDA class 1 | Physical Medicine |
Other Clearances by Hosmer Dorrance Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K822632 | ELBOW PROSTHESIS | Sep 14, 1982 | Substantially Equivalent |
| K821704 | FRACTURE BRACING | Jun 24, 1982 | Substantially Equivalent |
| K801788 | HUMEROUS FRACTURE BRACE, ULNA FRACTURE | Aug 7, 1980 | Substantially Equivalent |
| K780891 | POST-OPERATIVE HIP ORTHOSIS | Jun 13, 1978 | Substantially Equivalent |
| K780892 | FRACTURE BRACING | Jun 13, 1978 | Substantially Equivalent |
| K761312 | ORTHOTIC BRACING | Jan 10, 1977 | Substantially Equivalent |
| K761314 | FLEXION-BRAKING KNEE-SHIN ASSEMBLY | Jan 10, 1977 | Substantially Equivalent |
| K761313 | 4-BAR KNEE-SHIN SET-UP | Jan 10, 1977 | Substantially Equivalent |