The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Manan General Purpose Introducer Needle.
| Device ID | K980004 |
| 510k Number | K980004 |
| Device Name: | MANAN GENERAL PURPOSE INTRODUCER NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | Karl Swartz MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 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 | 1998-01-02 |
| Decision Date | 1998-01-09 |
| Summary: | summary |