The following data is part of a premarket notification filed by Percutaneous Systems, Inc. with the FDA for Slip Urology Introducer Sheath.
| Device ID | K040520 |
| 510k Number | K040520 |
| Device Name: | SLIP UROLOGY INTRODUCER SHEATH |
| Classification | Accessories, Catheter, G-u |
| Applicant | PERCUTANEOUS SYSTEMS, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein PERCUTANEOUS SYSTEMS, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-27 |
| Decision Date | 2004-05-20 |
| Summary: | summary |