The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Sniper, Model Or-3872xx Series.
| Device ID | K001251 |
| 510k Number | K001251 |
| Device Name: | SNIPER, MODEL OR-3872XX SERIES |
| Classification | Wire, Guide, Catheter |
| Applicant | NIPRO MEDICAL CORP. 1445 FLAT GREEK RD. Athens, TX |
| Contact | Jack Frautschi |
| Correspondent | Jack Frautschi NIPRO MEDICAL CORP. 1445 FLAT GREEK RD. Athens, TX |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-19 |
| Decision Date | 2000-07-07 |