The following data is part of a premarket notification filed by Boston Endoscopic Engineering with the FDA for Bnx Fine Needle Aspiration System.
| Device ID | K103668 |
| 510k Number | K103668 |
| Device Name: | BNX FINE NEEDLE ASPIRATION SYSTEM |
| Classification | Biopsy Needle |
| Applicant | BOSTON ENDOSCOPIC ENGINEERING 53 KENNEDY ROAD Foster, RI 02825 |
| Contact | Annette M Fagnant |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-12-16 |
| Decision Date | 2010-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855208005070 | K103668 | 000 |
| 00855208005063 | K103668 | 000 |
| 00855208005056 | K103668 | 000 |
| 00855208005049 | K103668 | 000 |
| 00855208005032 | K103668 | 000 |
| 00855208005025 | K103668 | 000 |
| 00855208005018 | K103668 | 000 |
| 00855208005001 | K103668 | 000 |