3M Maxi-Driver II Electric System
FDA 510(k) K951118 · 3M Company
510(k) numberK951118
Submission
- Device name
- 3M Maxi-Driver II Electric System
- Applicant
- 3M Company
Burbank, CA, US - Received
- March 10, 1995
- Decision date
- July 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
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Questions and answers
When was 3M Maxi-Driver II Electric System cleared by the FDA?
3M Maxi-Driver II Electric System (K951118) received a 510(k) decision of Substantially Equivalent on July 6, 1995, 118 days after the submission was received.
What is the product code of K951118?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.