FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARAGLAS XTRA SYNTHETIC CASTING TAPE
K Number: K896634
·
Decision Jun 14, 1990
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
30
Applicant Total
111
Review Days
204
Basic Information
- Device Name
- CARAGLAS XTRA SYNTHETIC CASTING TAPE
- K Number
- K896634
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5940
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- BUCKMAN CO., INC.
- Date Received
- November 22, 1989
- Decision Date
- June 14, 1990
- Product Code
- LGF
- 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 |
|---|---|---|---|
| LGF | Component, Cast | FDA class 1 | Orthopedic |
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