The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Systems Integration.
| Device ID | K121701 |
| 510k Number | K121701 |
| Device Name: | SYSTEMS INTEGRATION |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-08 |
| Decision Date | 2012-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170390616 | K121701 | 000 |
| 04953170363016 | K121701 | 000 |
| 04953170352881 | K121701 | 000 |
| 04953170335464 | K121701 | 000 |
| 04953170313585 | K121701 | 000 |
| 04953170286018 | K121701 | 000 |
| 04953170286001 | K121701 | 000 |
| 04953170148064 | K121701 | 000 |
| 04953170328985 | K121701 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SYSTEMS INTEGRATION 73798618 1597966 Dead/Cancelled |
REED PUBLISHING (USA) INC. 1989-05-08 |