FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER-THRU-NEEDLE DEVICE
K Number: K770403
·
Decision Mar 16, 1977
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
883
Review Days
13
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Basic Information
- Device Name
- CATHETER-THRU-NEEDLE DEVICE
- K Number
- K770403
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- March 3, 1977
- Decision Date
- March 16, 1977
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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