The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Percutaneous Nephrostomy Sets (gunther).
| Device ID | K854907 |
| 510k Number | K854907 |
| Device Name: | PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) |
| Classification | Catheter, Nephrostomy, General & Plastic Surgery |
| Applicant | ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Contact | Richard P Mohr |
| Correspondent | Richard P Mohr ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Product Code | GBO |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-09 |
| Decision Date | 1986-01-24 |