The following data is part of a premarket notification filed by Noetix, Inc. with the FDA for Noetix, Biopsy Needle.
| Device ID | K893992 |
| 510k Number | K893992 |
| Device Name: | NOETIX, BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | NOETIX, INC. 5602 ELMWOOD AVE., STE.122, ELMWOOD PARK Indianapolis, IN 46203 |
| Contact | Joseph Mark |
| Correspondent | Joseph Mark NOETIX, INC. 5602 ELMWOOD AVE., STE.122, ELMWOOD PARK Indianapolis, IN 46203 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-05 |
| Decision Date | 1989-09-08 |