FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEOLOOPS
K Number: K810890
·
Decision Aug 31, 1981
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
1
Review Days
151
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Basic Information
- Device Name
- NEOLOOPS
- K Number
- K810890
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medical Marketing Systems
- Date Received
- April 2, 1981
- Decision Date
- August 31, 1981
- 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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