The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Disposal Lens Cleaning Sheath.
| Device ID | K153773 |
| 510k Number | K153773 |
| Device Name: | Disposal Lens Cleaning Sheath |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-31 |
| Decision Date | 2016-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170366864 | K153773 | 000 |
| 04953170366895 | K153773 | 000 |
| 04953170353185 | K153773 | 000 |