FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED CHICK AMBULATORY HALO
K Number: K884242
·
Decision Dec 29, 1988
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
84
Applicant Total
2
Review Days
79
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Basic Information
- Device Name
- MODIFIED CHICK AMBULATORY HALO
- K Number
- K884242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Chick Medical Products
- Date Received
- October 11, 1988
- Decision Date
- December 29, 1988
- Product Code
- JEC
- 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | FDA class 2 | Orthopedic |
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Other Clearances by Chick Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K901830 | CHICK III SURGICAL LIGHTING SYSTEM | May 24, 1990 | Substantially Equivalent |