The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Pbn Fallopian Tube Catheter System.
| Device ID | K000620 |
| 510k Number | K000620 |
| Device Name: | PBN FALLOPIAN TUBE CATHETER SYSTEM |
| Classification | System, Intrafallopian Cannula |
| 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 | MDG |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-24 |
| Decision Date | 2000-10-30 |