FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K Number: K001616
·
Decision Jul 27, 2000
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
883
Review Days
63
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Basic Information
- Device Name
- MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
- K Number
- K001616
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Abbott Laboratories
- Date Received
- May 25, 2000
- Decision Date
- July 27, 2000
- 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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