Coloplast Baby Urine Collectors
FDA 510(k) K833570 · Coloplast A/S
510(k) numberK833570
Submission
- Device name
- Coloplast Baby Urine Collectors
- Applicant
- Coloplast A/S
Mchenry, IL, US - Received
- October 12, 1983
- Decision date
- January 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Coloplast Baby Urine Collectors cleared by the FDA?
Coloplast Baby Urine Collectors (K833570) received a 510(k) decision of Substantially Equivalent on January 30, 1984, 110 days after the submission was received.
What is the product code of K833570?
The FDA product code is KNX – Collector, Urine, (And Accessories) For Indwelling Catheter, a Class II (moderate risk) device regulated under 21 CFR 876.5250.