FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DELTA-LITE CASTING RESIN
K Number: K854341
·
Decision Nov 22, 1985
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
30
Applicant Total
206
Review Days
25
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Basic Information
- Device Name
- DELTA-LITE CASTING RESIN
- K Number
- K854341
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5940
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- October 28, 1985
- Decision Date
- November 22, 1985
- 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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