The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Cd-6c-1 Coagulation Electrode.
| Device ID | K971328 |
| 510k Number | K971328 |
| Device Name: | OLYMPUS CD-6C-1 COAGULATION ELECTRODE |
| Classification | System, Water Jet Catheter, Renal |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Subhash R Patel |
| Correspondent | Subhash R Patel OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FFE |
| CFR Regulation Number | 876.4650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-07-01 |