The following data is part of a premarket notification filed by Angeion Corp. with the FDA for Angeion Endoscopic Valve Seal.
| Device ID | K915719 |
| 510k Number | K915719 |
| Device Name: | ANGEION ENDOSCOPIC VALVE SEAL |
| Classification | Endoscope Channel Accessory |
| Applicant | ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Contact | Steven W Hentley |
| Correspondent | Steven W Hentley ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-02-18 |