The following data is part of a premarket notification filed by Surgical Innovations Plc with the FDA for Numo Nm-1000 Automatic Carbon-dioxide For Endoscope.
| Device ID | K955393 |
| 510k Number | K955393 |
| Device Name: | NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE |
| Classification | Insufflator, Laparoscopic |
| Applicant | SURGICAL INNOVATIONS PLC 1070 THORNWOOD LN. Dacula, GA 30211 -3007 |
| Contact | Michael A Clark |
| Correspondent | Michael A Clark SURGICAL INNOVATIONS PLC 1070 THORNWOOD LN. Dacula, GA 30211 -3007 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-24 |
| Decision Date | 1997-01-09 |