The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Hys-surgiflator 150p.
| Device ID | K983889 |
| 510k Number | K983889 |
| Device Name: | HYS-SURGIFLATOR 150P |
| Classification | Insufflator, Hysteroscopic |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH 194 BRANCH ST. Mansfield, MA 02048 |
| Contact | Michael Mcgrail |
| Correspondent | Michael Mcgrail W.O.M. WORLD OF MEDICINE, GMBH 194 BRANCH ST. Mansfield, MA 02048 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1999-01-14 |
| Summary: | summary |