The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Manan Vs Access Needle/set.
| Device ID | K980372 |
| 510k Number | K980372 |
| Device Name: | MANAN VS ACCESS NEEDLE/SET |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| 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 | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-30 |
| Decision Date | 1998-04-27 |
| Summary: | summary |