The following data is part of a premarket notification filed by Ispg, Inc. with the FDA for Chiba Needle.
| Device ID | K012358 |
| 510k Number | K012358 |
| Device Name: | CHIBA NEEDLE |
| Classification | Biopsy Needle |
| Applicant | ISPG, INC. 517 LITCHFIELD RD. New Milford, CT 06776 |
| Contact | Loretta F Luhman |
| Correspondent | Loretta F Luhman ISPG, INC. 517 LITCHFIELD RD. New Milford, CT 06776 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-25 |
| Decision Date | 2001-10-15 |