Lifeshield Blunt Cannula
FDA 510(k) K963351 · Abbott Laboratories
510(k) numberK963351
Submission
- Device name
- Lifeshield Blunt Cannula
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 26, 1996
- Decision date
- February 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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Questions and answers
When was Lifeshield Blunt Cannula cleared by the FDA?
Lifeshield Blunt Cannula (K963351) received a 510(k) decision of Substantially Equivalent on February 26, 1997, 184 days after the submission was received.
What is the product code of K963351?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.