The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Hys-surgiflator.
| Device ID | K924523 |
| 510k Number | K924523 |
| Device Name: | HYS-SURGIFLATOR |
| Classification | Insufflator, Hysteroscopic |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH C/O QUALITIVITY 8536 CALLE TIOGA Tucson, AZ 85704 -6508 |
| Contact | Owen B Lamb |
| Correspondent | Owen B Lamb W.O.M. WORLD OF MEDICINE, GMBH C/O QUALITIVITY 8536 CALLE TIOGA Tucson, AZ 85704 -6508 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-08 |
| Decision Date | 1995-04-11 |