The following data is part of a premarket notification filed by Rg Medical Usa with the FDA for Reusable, Disposable Laparoscopic Instrument And Surgical Device And Accessories.
| Device ID | K072753 |
| 510k Number | K072753 |
| Device Name: | REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES |
| Classification | Insufflator, Laparoscopic |
| Applicant | RG MEDICAL USA 468 CRAIGHEAD ST. Nashville, TN 37204 |
| Contact | Winfried Reich |
| Correspondent | Winfried Reich RG MEDICAL USA 468 CRAIGHEAD ST. Nashville, TN 37204 |
| Product Code | HIF |
| Subsequent Product Code | EYN |
| Subsequent Product Code | FMT |
| Subsequent Product Code | FPB |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | JOK |
| Subsequent Product Code | NGY |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-27 |
| Decision Date | 2008-01-25 |