The following data is part of a premarket notification filed by Benlan Inc with the FDA for Med-rx Extension Set With T-connector.
Device ID | K112799 |
510k Number | K112799 |
Device Name: | MED-RX EXTENSION SET WITH T-CONNECTOR |
Classification | Set, Administration, Intravascular |
Applicant | BENLAN INC 2760 BRIGHTON RD Oakville, CA L6h 5t4 |
Contact | Cheryl Brown |
Correspondent | Cheryl Brown BENLAN INC 2760 BRIGHTON RD Oakville, CA L6h 5t4 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-27 |
Decision Date | 2011-12-23 |
Summary: | summary |