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 |