The following data is part of a premarket notification filed by Galenica Enterprises, Inc. with the FDA for Disposable Amniotome.
| Device ID | K883283 |
| 510k Number | K883283 |
| Device Name: | DISPOSABLE AMNIOTOME |
| Classification | Controller, Abortion Unit, Vacuum |
| Applicant | GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7, CA |
| Contact | Jacques R Marcotte |
| Correspondent | Jacques R Marcotte GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7, CA |
| Product Code | HGG |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-04 |
| Decision Date | 1988-10-18 |