The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Na-10j-1 Aspiration Needle.
| Device ID | K973128 |
| 510k Number | K973128 |
| Device Name: | OLYMPUS NA-10J-1 ASPIRATION NEEDLE |
| Classification | Hood, Oxygen, Infant |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Subhash R Patel |
| Correspondent | Subhash R Patel OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FOG |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-21 |
| Decision Date | 1997-11-18 |
| Summary: | summary |