The following data is part of a premarket notification filed by Look, Inc. with the FDA for Look Fluid Distribution Set.
Device ID | K872945 |
510k Number | K872945 |
Device Name: | LOOK FLUID DISTRIBUTION SET |
Classification | Set, Administration, Intravascular |
Applicant | LOOK, INC. 45 CHARLES PARK RD. Boston, MA 02132 |
Contact | David H Barrett |
Correspondent | David H Barrett LOOK, INC. 45 CHARLES PARK RD. Boston, MA 02132 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-28 |
Decision Date | 1987-10-22 |