The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Epic Introducer Sheath.
| Device ID | K960310 |
| 510k Number | K960310 |
| Device Name: | EPIC INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. PRUYNS ISLAND RD. Glens Falls, NY 12801 |
| Contact | Mary Meagher-rubin |
| Correspondent | Mary Meagher-rubin NORTH AMERICAN INSTRUMENT CORP. PRUYNS ISLAND RD. Glens Falls, NY 12801 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-22 |
| Decision Date | 1996-02-07 |