The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab I.v. Administration Sets.
Device ID | K883318 |
510k Number | K883318 |
Device Name: | VALLEYLAB I.V. ADMINISTRATION SETS |
Classification | Set, Administration, Intravascular |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | Peggy Walline |
Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-05 |
Decision Date | 1988-10-21 |