The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Manan Galactography Kit.
| Device ID | K980227 |
| 510k Number | K980227 |
| Device Name: | MANAN GALACTOGRAPHY KIT |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-22 |
| Decision Date | 1998-04-23 |
| Summary: | summary |