The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Ultralith Ultrasonic Lithotripsy System.
| Device ID | K850298 |
| 510k Number | K850298 |
| Device Name: | ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM |
| Classification | Lithotriptor, Ultrasonic |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | David E Gronostajsk |
| Correspondent | David E Gronostajsk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | FEO |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-24 |
| Decision Date | 1985-03-05 |