The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for A Range Of Instruments & Plates For Mandibular Com.
| Device ID | K853709 |
| 510k Number | K853709 |
| Device Name: | A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM |
| Classification | Plate, Fixation, Bone |
| Applicant | DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | Jarvis Cribb |
| Correspondent | Jarvis Cribb DOWNS SURGICAL LTD. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-04 |
| Decision Date | 1985-11-15 |