The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical Variable Flow Insufflator.
| Device ID | K862310 |
| 510k Number | K862310 |
| Device Name: | CABOT MEDICAL VARIABLE FLOW INSUFFLATOR |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Louis A Angelucci |
| Correspondent | Louis A Angelucci CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-17 |
| Decision Date | 1986-08-12 |