The following data is part of a premarket notification filed by Macan Engineering Co. with the FDA for Mc6a.
| Device ID | K050735 |
| 510k Number | K050735 |
| Device Name: | MC6A |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | MACAN ENGINEERING CO. 1564 NORTH DAMEN AVE. Chicago, IL 60622 |
| Contact | Rich Garrett |
| Correspondent | Rich Garrett MACAN ENGINEERING CO. 1564 NORTH DAMEN AVE. Chicago, IL 60622 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853404007515 | K050735 | 000 |
| 00851683006151 | K050735 | 000 |
| 00851683006106 | K050735 | 000 |
| 00851683006069 | K050735 | 000 |
| 00851683006014 | K050735 | 000 |