Montblanc Surgical Contra-Angle and Straight Handpiece
FDA 510(k) K111532 · Anthogyr Sas
510(k) numberK111532
Submission
- Device name
- Montblanc Surgical Contra-Angle and Straight Handpiece
- Applicant
- Anthogyr Sas
Sallanches, FR - Received
- June 3, 2011
- Decision date
- October 7, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Montblanc Surgical Contra-Angle and Straight Handpiece cleared by the FDA?
Montblanc Surgical Contra-Angle and Straight Handpiece (K111532) received a 510(k) decision of Substantially Equivalent on October 7, 2011, 126 days after the submission was received.
What is the product code of K111532?
The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.