The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Solution Admini. Sets- Alter. Drip Chamber/connec..
Device ID | K870940 |
510k Number | K870940 |
Device Name: | SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC. |
Classification | Set, Administration, Intravascular |
Applicant | TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Contact | Julia A Meyer |
Correspondent | Julia A Meyer TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake, IL 60073 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-09 |
Decision Date | 1987-03-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50085412082788 | K870940 | 000 |
50085412082429 | K870940 | 000 |
50085412078385 | K870940 | 000 |
50085412015472 | K870940 | 000 |