Tri-Phasix Chromatic Alginate
FDA 510(k) K962741 · Parkell, Inc.
510(k) numberK962741
Submission
- Device name
- Tri-Phasix Chromatic Alginate
- Applicant
- Parkell, Inc.
Farmingdale, NY, US - Received
- July 15, 1996
- Decision date
- September 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Tri-Phasix Chromatic Alginate cleared by the FDA?
Tri-Phasix Chromatic Alginate (K962741) received a 510(k) decision of Substantially Equivalent on September 6, 1996, 53 days after the submission was received.
What is the product code of K962741?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.