The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Seldinger Single Wall; Style I & Ii (flashback).
| Device ID | K895454 |
| 510k Number | K895454 |
| Device Name: | SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) |
| Classification | Trocar |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-05 |
| Decision Date | 1989-11-14 |