Comfeel Paste
FDA 510(k) K840362 · Coloplast A/S
510(k) numberK840362
Submission
- Device name
- Comfeel Paste
- Applicant
- Coloplast A/S
Fort Worth, TX, US - Received
- January 26, 1984
- Decision date
- November 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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Questions and answers
When was Comfeel Paste cleared by the FDA?
Comfeel Paste (K840362) received a 510(k) decision of Substantially Equivalent on November 7, 1984, 286 days after the submission was received.