The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Hysteroflator 2001.
| Device ID | K895907 |
| 510k Number | K895907 |
| Device Name: | HYSTEROFLATOR 2001 |
| Classification | Insufflator, Hysteroscopic |
| 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 | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-06 |
| Decision Date | 1989-12-14 |