Aroma Fine (Normal and Fast Set)
FDA 510(k) K994077 · GC America, Inc.
510(k) numberK994077
Submission
- Device name
- Aroma Fine (Normal and Fast Set)
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- December 2, 1999
- Decision date
- January 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Aroma Fine (Normal and Fast Set) cleared by the FDA?
Aroma Fine (Normal and Fast Set) (K994077) received a 510(k) decision of Substantially Equivalent on January 27, 2000, 56 days after the submission was received.
What is the product code of K994077?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.