The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Biopince Ultra Full Core Biopsy Instrument.
| Device ID | K101832 |
| 510k Number | K101832 |
| Device Name: | BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT |
| Classification | Instrument, Biopsy |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 3600 S.W. 47TH AVE. Gainesville, FL 32608 |
| Contact | Trudy D Estridge |
| Correspondent | Trudy D Estridge MEDICAL DEVICE TECHNOLOGIES, INC. 3600 S.W. 47TH AVE. Gainesville, FL 32608 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-08-27 |
| Summary: | summary |