FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOSURGE MODEL ILVC-1
K Number: K875016
·
Decision Feb 29, 1988
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
5
Review Days
87
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Basic Information
- Device Name
- BIOSURGE MODEL ILVC-1
- K Number
- K875016
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Biosurge, Inc.
- Date Received
- December 4, 1987
- Decision Date
- February 29, 1988
- Product Code
- DWS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | FDA class 1 | Cardiovascular |
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