Modified Site Power Handpiece II
FDA 510(k) K932600 · Chiron Vision Corp.
510(k) numberK932600
Submission
- Device name
- Modified Site Power Handpiece II
- Applicant
- Chiron Vision Corp.
Horsham, PA, US - Received
- May 28, 1993
- Decision date
- January 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Modified Site Power Handpiece II cleared by the FDA?
Modified Site Power Handpiece II (K932600) received a 510(k) decision of Substantially Equivalent on January 25, 1994, 242 days after the submission was received.
What is the product code of K932600?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.