The following data is part of a premarket notification filed by Hart Enterprises, Inc. with the FDA for Needle Insert For Soft Tissue Biopsy Device.
| Device ID | K885149 |
| 510k Number | K885149 |
| Device Name: | NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE |
| Classification | Needle, Biopsy, Cardiovascular |
| Applicant | HART ENTERPRISES, INC. 2131 MARTINDALE SW Wyoming, MI 49509 |
| Contact | Alan Taylor |
| Correspondent | Alan Taylor HART ENTERPRISES, INC. 2131 MARTINDALE SW Wyoming, MI 49509 |
| Product Code | DWO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-15 |
| Decision Date | 1989-01-26 |