The following data is part of a premarket notification filed by Erchinger Medizintecnik with the FDA for Erchinger Hemorrhoidal Ligators: Suction Ligators, Mod. Erchinger, Rudd, Mcgivney Mod. Erchinger.
| Device ID | K000297 |
| 510k Number | K000297 |
| Device Name: | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER |
| Classification | Ligator, Hemorrhoidal |
| Applicant | ERCHINGER MEDIZINTECNIK AMSTEL 320 I Amsterdam, NL 1017 Ap |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser ERCHINGER MEDIZINTECNIK AMSTEL 320 I Amsterdam, NL 1017 Ap |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-31 |
| Decision Date | 2000-04-24 |