Modification to Syringe Prefilled with 0.9% Sodium Chloride
FDA 510(k) K001616 · Abbott Laboratories
510(k) numberK001616
Submission
- Device name
- Modification to Syringe Prefilled with 0.9% Sodium Chloride
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- May 25, 2000
- Decision date
- July 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
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Questions and answers
When was Modification to Syringe Prefilled with 0.9% Sodium Chloride cleared by the FDA?
Modification to Syringe Prefilled with 0.9% Sodium Chloride (K001616) received a 510(k) decision of Substantially Equivalent on July 27, 2000, 63 days after the submission was received.
What is the product code of K001616?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.