The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Specialty Set Model Iv7a01.
Device ID | K830891 |
510k Number | K830891 |
Device Name: | SPECIALTY SET MODEL IV7A01 |
Classification | Set, Administration, Intravascular |
Applicant | VALLEYLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-21 |
Decision Date | 1983-04-14 |