Micro-Aire Model 2060
FDA 510(k) K913369 · Micro Surgical Instruments Corp.
510(k) numberK913369
Submission
- Device name
- Micro-Aire Model 2060
- Applicant
- Micro Surgical Instruments Corp.
Valencia, CA, US - Received
- July 29, 1991
- Decision date
- November 1, 1991
- 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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| K913266 | Micro-Aire Model 2050E/ELEC Handpiece/TrottlelessGEY · Traditional | 10/21/1991SE |
| K910175 | Fixation Devices and Bone PlateHRS · Traditional | 06/21/1991SN |
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Questions and answers
When was Micro-Aire Model 2060 cleared by the FDA?
Micro-Aire Model 2060 (K913369) received a 510(k) decision of Substantially Equivalent on November 1, 1991, 95 days after the submission was received.
What is the product code of K913369?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.