Kangaroo Enteral Feeding Extension Set for Syringe Pumps
FDA 510(k) K973409 · Davis & Geck, Inc.
510(k) numberK973409
Submission
- Device name
- Kangaroo Enteral Feeding Extension Set for Syringe Pumps
- Applicant
- Davis & Geck, Inc.
Hazlewood, MO, US - Received
- September 9, 1997
- Decision date
- February 27, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
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Questions and answers
When was Kangaroo Enteral Feeding Extension Set for Syringe Pumps cleared by the FDA?
Kangaroo Enteral Feeding Extension Set for Syringe Pumps (K973409) received a 510(k) decision of Substantially Equivalent on February 27, 1998, 171 days after the submission was received.
What is the product code of K973409?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.