FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RECEPTAL ATS MEDIASTINAL LINER
K Number: K772280
·
Decision Jan 3, 1978
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
69
Review Days
25
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Basic Information
- Device Name
- RECEPTAL ATS MEDIASTINAL LINER
- K Number
- K772280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sorensen Research
- Date Received
- December 9, 1977
- Decision Date
- January 3, 1978
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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