FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODULAR EXTREMITY CASTING SUPPORT
K Number: K834384
·
Decision Jan 30, 1984
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
2
Applicant Total
111
Review Days
47
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Basic Information
- Device Name
- MODULAR EXTREMITY CASTING SUPPORT
- K Number
- K834384
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5980
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Buckman Co., Inc.
- Date Received
- December 14, 1983
- Decision Date
- January 30, 1984
- Product Code
- LGG
- 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 |
|---|---|---|---|
| LGG | Instrument, Cast Application/Removal, Manual | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGG), ordered by most recent decision date.
PLASTER STAND
FDA 510(k)
FDA Class 1
·Orthopedic
27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF
FDA 510(k)
FDA Class 1
·Orthopedic
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