The following data is part of a premarket notification filed by Replication Medical Inc with the FDA for Replication Medical Vessel Guard.
| Device ID | K082782 |
| 510k Number | K082782 |
| Device Name: | REPLICATION MEDICAL VESSEL GUARD |
| Classification | Vessel Guard Or Cover |
| Applicant | REPLICATION MEDICAL INC 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Contact | Marcos Velez-duran |
| Correspondent | Marcos Velez-duran REPLICATION MEDICAL INC 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Product Code | OMR |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2009-04-02 |
| Summary: | summary |