The following data is part of a premarket notification filed by Oco Biomedical with the FDA for 6.00mm X 6.00mm Macro External Implant System.
| Device ID | K122198 |
| 510k Number | K122198 |
| Device Name: | 6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OCO BIOMEDICAL 9550 SAN MATEO BLVD NE, SUITE -C Albuquerque, NM 87113 |
| Contact | Jack Bloom |
| Correspondent | Jack Bloom OCO BIOMEDICAL 9550 SAN MATEO BLVD NE, SUITE -C Albuquerque, NM 87113 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-24 |
| Decision Date | 2013-04-05 |
| Summary: | summary |