The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Na-10j-kb Aspiration Needle.
| Device ID | K991672 |
| 510k Number | K991672 |
| Device Name: | OLYMPUS NA-10J-KB ASPIRATION NEEDLE |
| Classification | Biopsy Needle |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-17 |
| Decision Date | 1999-11-03 |
| Summary: | summary |