The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Interv Brand Snarelok Bone Marrow Biopsy Needle.
| Device ID | K043523 |
| 510k Number | K043523 |
| Device Name: | INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 241 W. PALATINE ROAD Wheeling, IL 60090 |
| Contact | Nicohl Wilding |
| Correspondent | Nicohl Wilding MEDICAL DEVICE TECHNOLOGIES, INC. 241 W. PALATINE ROAD Wheeling, IL 60090 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-02-11 |
| Summary: | summary |