The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Iv Administration Set.
Device ID | K871908 |
510k Number | K871908 |
Device Name: | IV ADMINISTRATION SET |
Classification | Set, Blood Transfusion |
Applicant | TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Contact | Dennis Ocwieja |
Correspondent | Dennis Ocwieja TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Product Code | BRZ |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-15 |
Decision Date | 1987-07-27 |