The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model Iv 1500 Standard Burette.
Device ID | K781637 |
510k Number | K781637 |
Device Name: | MODEL IV 1500 STANDARD BURETTE |
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 | 1978-09-21 |
Decision Date | 1978-12-12 |