The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for System 3000 Electronic Insufflator.
| Device ID | K913873 |
| 510k Number | K913873 |
| Device Name: | SYSTEM 3000 ELECTRONIC INSUFFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | David T Jamison |
| Correspondent | David T Jamison CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-29 |
| Decision Date | 1992-03-20 |