The following data is part of a premarket notification filed by Sopro with the FDA for Sopro Model 640 Laparoscopic Insufflator.
| Device ID | K070783 |
| 510k Number | K070783 |
| Device Name: | SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Steve Salesky |
| Correspondent | Steve Salesky SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-21 |
| Decision Date | 2007-12-13 |
| Summary: | summary |