The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Ocs-2 Colposcope.
| Device ID | K852980 |
| 510k Number | K852980 |
| Device Name: | OCS-2 COLPOSCOPE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Walter J Seidl |
| Correspondent | Walter J Seidl OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-15 |
| Decision Date | 1985-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170331770 | K852980 | 000 |
| 04953170331688 | K852980 | 000 |
| 04953170331695 | K852980 | 000 |
| 04953170331701 | K852980 | 000 |
| 04953170331718 | K852980 | 000 |
| 04953170331725 | K852980 | 000 |
| 04953170331732 | K852980 | 000 |
| 04953170331749 | K852980 | 000 |
| 04953170331756 | K852980 | 000 |
| 04953170331763 | K852980 | 000 |
| 04953170331671 | K852980 | 000 |