The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Surgiflator-20 Pim.
| Device ID | K955791 |
| 510k Number | K955791 |
| Device Name: | SURGIFLATOR-20 PIM |
| Classification | Insufflator, Laparoscopic |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton, DC 20005 -3306 |
| Contact | Robert P Reznick |
| Correspondent | Robert P Reznick W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton, DC 20005 -3306 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702003197 | K955791 | 000 |