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 |