Scotchprime Ceramic Primer
FDA 510(k) K853698 · 3M Company
510(k) numberK853698
Submission
- Device name
- Scotchprime Ceramic Primer
- Applicant
- 3M Company
Cottae Grove, MN, US - Received
- September 4, 1985
- Decision date
- November 14, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Scotchprime Ceramic Primer cleared by the FDA?
Scotchprime Ceramic Primer (K853698) received a 510(k) decision of Substantially Equivalent on November 14, 1985, 71 days after the submission was received.
What is the product code of K853698?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.