The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical Ultra Flow Cystourethroscope System With Operating & Diagnostic Sheaths.
| Device ID | K951972 |
| 510k Number | K951972 |
| Device Name: | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS |
| Classification | Cystourethroscope |
| 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 | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1995-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925027275 | K951972 | 000 |
| 00821925008243 | K951972 | 000 |
| 00821925008229 | K951972 | 000 |
| 00821925001916 | K951972 | 000 |