The following data is part of a premarket notification filed by Circon Video with the FDA for Circon Aeh-4 Electrohydraulic Lithotripsy Probe.
| Device ID | K011848 |
| 510k Number | K011848 |
| Device Name: | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Contact | Jerry Crouthers |
| Correspondent | Jerry Crouthers CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-13 |
| Decision Date | 2001-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925002449 | K011848 | 000 |
| 00821925001732 | K011848 | 000 |