The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for 3000 Electronic Insufflator Modification.
| Device ID | K934115 |
| 510k Number | K934115 |
| Device Name: | 3000 ELECTRONIC INSUFFLATOR MODIFICATION |
| Classification | Insufflator, Laparoscopic |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Todd J Polk |
| Correspondent | Todd J Polk 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 | 1993-08-24 |
| Decision Date | 1995-03-15 |