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 | K970563 |
| 510k Number | K970563 |
| Device Name: | OLYMPUS NA-10J-1 ASPIRATION NEEDLE |
| Classification | Biopsy Needle |
| 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 | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-13 |
| Decision Date | 1997-04-11 |
| Summary: | summary |