The following data is part of a premarket notification filed by North American Sterilization & Packaging Co. with the FDA for Nortec Ureteral Stent.
| Device ID | K910691 |
| 510k Number | K910691 |
| Device Name: | NORTEC URETERAL STENT |
| Classification | Stent, Ureteral |
| Applicant | NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
| Contact | Harry A Schlakman |
| Correspondent | Harry A Schlakman NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-19 |
| Decision Date | 1991-08-15 |