The following data is part of a premarket notification filed by Galenica Enterprises, Inc. with the FDA for Galenica's Disposable Anoscopes.
| Device ID | K861017 |
| 510k Number | K861017 |
| Device Name: | GALENICA'S DISPOSABLE ANOSCOPES |
| Classification | Anoscope And Accessories |
| Applicant | GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7, CA |
| Contact | Jacques Marcotte |
| Correspondent | Jacques Marcotte GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7, CA |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-06-13 |