Spaceline High Volume Evacuation Handpie
FDA 510(k) K801682 · Pacific Dental Corp.
510(k) numberK801682
Submission
- Device name
- Spaceline High Volume Evacuation Handpie
- Applicant
- Pacific Dental Corp.
Mchenry, IL, US - Received
- July 21, 1980
- Decision date
- August 4, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Spaceline High Volume Evacuation Handpie cleared by the FDA?
Spaceline High Volume Evacuation Handpie (K801682) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 14 days after the submission was received.
What is the product code of K801682?
The FDA product code is EHZ – Evacuator, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6640.