The following data is part of a premarket notification filed by Circon Acmi with the FDA for Aeh-3 Electrohydraulic Lithotripter And Probes (e-1f, E-3f, E-5f, And E-9f).
| Device ID | K980492 |
| 510k Number | K980492 |
| Device Name: | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-09 |
| Decision Date | 1998-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925002050 | K980492 | 000 |
| 00821925002043 | K980492 | 000 |
| 00821925002241 | K980492 | 000 |
| 00821925002234 | K980492 | 000 |