Monojectt Bluntip I.V. Access Cannula with Vial Access Pin Device
FDA 510(k) K980062 · Davis & Geck, Inc.
510(k) numberK980062
Submission
- Device name
- Monojectt Bluntip I.V. Access Cannula with Vial Access Pin Device
- Applicant
- Davis & Geck, Inc.
Hazlewood, MO, US - Received
- January 7, 1998
- Decision date
- March 20, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Monojectt Bluntip I.V. Access Cannula with Vial Access Pin Device cleared by the FDA?
Monojectt Bluntip I.V. Access Cannula with Vial Access Pin Device (K980062) received a 510(k) decision of Substantially Equivalent on March 20, 1998, 72 days after the submission was received.
What is the product code of K980062?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.