The following data is part of a premarket notification filed by Atlas Technology with the FDA for Plaquagrafe, Agrafe P4v.
| Device ID | K974603 |
| 510k Number | K974603 |
| Device Name: | PLAQUAGRAFE, AGRAFE P4V |
| Classification | Plate, Fixation, Bone |
| Applicant | ATLAS TECHNOLOGY 344 ANNABELLE POINT RD. Centerville,, MA 02632 -2402 |
| Contact | Hillard W Welch |
| Correspondent | Hillard W Welch ATLAS TECHNOLOGY 344 ANNABELLE POINT RD. Centerville,, MA 02632 -2402 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-10 |
| Decision Date | 1998-03-10 |