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 |