FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENT-A-CAST
K Number: K843780
·
Decision Nov 14, 1984
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
30
Applicant Total
2
Review Days
49
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Basic Information
- Device Name
- VENT-A-CAST
- K Number
- K843780
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5940
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Orthopedic Technology, Inc.
- Date Received
- September 26, 1984
- Decision Date
- November 14, 1984
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGF), ordered by most recent decision date.
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Other Clearances by Orthopedic Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940429 | ORTHO TECH CRYOLOGIC SYSTEM | Jul 12, 1994 | Substantially Equivalent for Some Indications |