The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Roller Electrode.
| Device ID | K954488 |
| 510k Number | K954488 |
| Device Name: | ROLLER ELECTRODE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1997-03-06 |