Fluocal Gel Orange
FDA 510(k) K760799 · Septodont, Inc.
510(k) numberK760799
Submission
- Device name
- Fluocal Gel Orange
- Applicant
- Septodont, Inc.
Mchenry, IL, US - Received
- October 8, 1976
- Decision date
- November 24, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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Questions and answers
When was Fluocal Gel Orange cleared by the FDA?
Fluocal Gel Orange (K760799) received a 510(k) decision of Substantially Equivalent on November 24, 1976, 47 days after the submission was received.