The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus High Flow Insufflation Unit.
| Device ID | K953162 |
| 510k Number | K953162 |
| Device Name: | OLYMPUS HIGH FLOW INSUFFLATION UNIT |
| Classification | Insufflator, Laparoscopic |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-07 |
| Decision Date | 1995-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170152856 | K953162 | 000 |
| 04953170053627 | K953162 | 000 |
| 04953170023170 | K953162 | 000 |
| 10817183020629 | K953162 | 000 |
| 10817183020414 | K953162 | 000 |