The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Laser Laparoscopy Accessory Set.
| Device ID | K862228 |
| 510k Number | K862228 |
| Device Name: | CABOT LASER LAPAROSCOPY ACCESSORY SET |
| Classification | Laser, Surgical, Gynecologic |
| 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 | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-11 |
| Decision Date | 1986-08-20 |