The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Surgiflator-30.
| Device ID | K973432 |
| 510k Number | K973432 |
| Device Name: | SURGIFLATOR-30 |
| Classification | Insufflator, Laparoscopic |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH PASCALSTRABE 11 Berlin, DE D-10587 |
| Contact | Robert P Reznick |
| Correspondent | Robert P Reznick W.O.M. WORLD OF MEDICINE, GMBH PASCALSTRABE 11 Berlin, DE D-10587 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-10 |
| Decision Date | 1997-12-09 |
| Summary: | summary |