The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Pbn Dilators.
| Device ID | K990808 |
| 510k Number | K990808 |
| Device Name: | PBN DILATORS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | Karl Swartz MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Product Code | FGE |
| Subsequent Product Code | GCC |
| Subsequent Product Code | LJE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-11 |
| Decision Date | 1999-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333004960 | K990808 | 000 |
| 20886333004953 | K990808 | 000 |
| 20886333004946 | K990808 | 000 |
| 20886333004939 | K990808 | 000 |
| 20886333004922 | K990808 | 000 |
| 20886333004915 | K990808 | 000 |
| 20886333004908 | K990808 | 000 |