The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Ultra-core Biopsy Needles.
| Device ID | K921418 |
| 510k Number | K921418 |
| Device Name: | ULTRA-CORE BIOPSY NEEDLES |
| Classification | Needle, Biopsy, Cardiovascular |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville, FL 32608 |
| Contact | Paul Baker |
| Correspondent | Paul Baker MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville, FL 32608 |
| Product Code | DWO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-06-19 |