Comfeel Ulcus Ulcer Care System
FDA 510(k) K873669 · Coloplast A/S
510(k) numberK873669
Submission
- Device name
- Comfeel Ulcus Ulcer Care System
- Applicant
- Coloplast A/S
Fort Woth, TX, US - Received
- September 11, 1987
- Decision date
- November 17, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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Questions and answers
When was Comfeel Ulcus Ulcer Care System cleared by the FDA?
Comfeel Ulcus Ulcer Care System (K873669) received a 510(k) decision of Substantially Equivalent for Some Indications on November 17, 1987, 67 days after the submission was received.
What is the product code of K873669?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.