Micro-Torque Hand Engine & Access. Dermabra. Burs
FDA 510(k) K873475 · Mcghan Medical Corp.
510(k) numberK873475
Submission
- Device name
- Micro-Torque Hand Engine & Access. Dermabra. Burs
- Applicant
- Mcghan Medical Corp.
Santa Barbara, CA, US - Received
- August 31, 1987
- Decision date
- September 11, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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More from Biomedical Ent., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873476 | Mini-Motor Hand Engine & Access. Dermabrasion BursGEY · Traditional | 09/11/1987SE |
| K870754 | Mcghan Tissue Expander Fill SystemLCJ · Traditional | 03/31/1987SE |
| K864185 | Mcghan Longterm Mammary Expander, RTV DesignLCJ · Traditional | 12/24/1986SE |
| K864184 | Mcghan Longterm Mammary Expander/Gel-Saline DesignLCJ · Traditional | 12/24/1986SE |
| K862203 | Mcghan Magna-Site(Tm) Tissue ExpanderLCJ · Traditional | 07/23/1986SE |
| K854794 | Mcghan Integral Valve Tissue ExpanderLCJ · Traditional | 12/24/1985SE |
| K853014 | Mcghan Tissue Expander Fill KitLCJ · Traditional | 09/18/1985SE |
| K843704 | Mcghan Tissue ExpanderLCJ · Traditional | 10/31/1984SE |
| K781087 | Medical Grade Silicone Elastomer TubingFPK · Traditional | 11/22/1978SE |
| K781700 | Ionotphoretic ApplicatorKTB · Traditional | 11/03/1978SE |
Questions and answers
When was Micro-Torque Hand Engine & Access. Dermabra. Burs cleared by the FDA?
Micro-Torque Hand Engine & Access. Dermabra. Burs (K873475) received a 510(k) decision of Substantially Equivalent on September 11, 1987, 11 days after the submission was received.
What is the product code of K873475?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.