FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROPOSED CONTROLS FOR DOSIMETRIC RELEASE
K Number: K812068
·
Decision Sep 8, 1981
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
42
Applicant Total
13
Review Days
49
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Basic Information
- Device Name
- PROPOSED CONTROLS FOR DOSIMETRIC RELEASE
- K Number
- K812068
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hexcel Medical
- Date Received
- July 21, 1981
- Decision Date
- September 8, 1981
- Product Code
- LIB
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | FDA class 1 | Microbiology |
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Other Clearances by Hexcel Medical
| K Number | Device Name | ||
|---|---|---|---|
| K840416 | HEXCELITE | Mar 23, 1984 | Substantially Equivalent |
| K820890 | URETHANE ORTHOPAEDIC CASTING TAPE | Jun 23, 1982 | Substantially Equivalent |
| K812669 | SEATTLE II TOTAL HIP SYSTEM | Oct 2, 1981 | Substantially Equivalent |
| K812687 | BRIGHAM II TOTAL HIP SYSTEM | Oct 2, 1981 | Substantially Equivalent |
| K811164 | URETHANE ORTHOPAEDIC CASTING TAPE | May 27, 1981 | Substantially Equivalent |
| K810956 | MARCOVE HUMERAL ROD | Apr 17, 1981 | Substantially Equivalent |
| K810957 | MARCOVE INTRAMEDULLARY ROD | Apr 17, 1981 | Substantially Equivalent |
| K810230 | CONDYLAR KNEE W/METAL ENCAPSULATED TIB | Mar 6, 1981 | Substantially Equivalent |
| K800051 | HEXCEL FEMORAL COMPONENT HIP PROSTHESIS | Jan 28, 1980 | Substantially Equivalent |
| K800050 | ANITOMIC TOTAL HIP SYSTEM | Jan 24, 1980 | Substantially Equivalent |