The following data is part of a premarket notification filed by Cair Lgl with the FDA for Carefusion Neutraclear Needle-free Connector.
Device ID | K171132 |
510k Number | K171132 |
Device Name: | Carefusion NeutraClear Needle-free Connector |
Classification | Set, Administration, Intravascular |
Applicant | CAIR LGL 1 Allee Des Chevreuils - BOIS DIEU Lissieu, FR 69380 |
Contact | Delphine Molinari |
Correspondent | Irving Wiesen WIESEN LAW OFFICES 420 Lexington Avenue - Suite 2400 New York, NY 10170 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-17 |
Decision Date | 2017-07-31 |
Summary: | summary |