Electric Surgical Irrigation System - Dual Controller Unit
FDA 510(k) K963843 · Micro Motors, Inc.
510(k) numberK963843
Submission
- Device name
- Electric Surgical Irrigation System - Dual Controller Unit
- Applicant
- Micro Motors, Inc.
Encinitas, CA, US - Received
- September 25, 1996
- Decision date
- March 31, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K911068 | 29540 Dynasurg Electric Handpiece and Irr. SystemEFB · Traditional | 05/15/1991SE |
| K903298 | Dynasonic Plaque Remover & Polisher DynatipELC · Traditional | 04/16/1991SE |
| K904850 | Dual and Single Irr. Systems Models 29550 & 29555EFS · Traditional | 01/25/1991SE |
| K896878 | Handpiece System with Motor (Several Models)EFB · Traditional | 03/08/1990SE |
| K896879 | Oral Surgery Handpiece and AttachmentsEFB · Traditional | 03/07/1990SE |
Questions and answers
When was Electric Surgical Irrigation System - Dual Controller Unit cleared by the FDA?
Electric Surgical Irrigation System - Dual Controller Unit (K963843) received a 510(k) decision of Substantially Equivalent on March 31, 1997, 187 days after the submission was received.
What is the product code of K963843?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.