The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Hys-surgiflator Vp.
| Device ID | K933847 |
| 510k Number | K933847 |
| Device Name: | HYS-SURGIFLATOR VP |
| Classification | Insufflator, Hysteroscopic |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton, DC 20005 -3306 |
| Contact | E. Keefer |
| Correspondent | E. Keefer W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton, DC 20005 -3306 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-06 |
| Decision Date | 1995-08-15 |