The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for High Flow Insufflation Unit Uhi-4.
| Device ID | K110294 |
| 510k Number | K110294 |
| Device Name: | HIGH FLOW INSUFFLATION UNIT UHI-4 |
| Classification | Insufflator, Laparoscopic |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Stacy Abbatiello Kluesner |
| Correspondent | Stacy Abbatiello Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-01 |
| Decision Date | 2011-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170324215 | K110294 | 000 |
| 04953170324208 | K110294 | 000 |
| 04953170324185 | K110294 | 000 |