The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Sniper Elite Model-or-e3872xx Series.
| Device ID | K011905 |
| 510k Number | K011905 |
| Device Name: | SNIPER ELITE MODEL-OR-E3872XX SERIES |
| Classification | Wire, Guide, Catheter |
| Applicant | MAXXIM MEDICAL 1445 FLAT CREEK RD. Athens, TX 75751 |
| Contact | Gail Doherty |
| Correspondent | Gail Doherty MAXXIM MEDICAL 1445 FLAT CREEK RD. Athens, TX 75751 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-19 |
| Decision Date | 2001-08-28 |
| Summary: | summary |