The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Pbn Hystero-salpingography Catheter Set.
Device ID | K000433 |
510k Number | K000433 |
Device Name: | PBN HYSTERO-SALPINGOGRAPHY CATHETER SET |
Classification | Cannula, Manipulator/injector, Uterine |
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 | LKF |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-09 |
Decision Date | 2000-06-16 |