The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Anti-aspiration Valve.
Device ID | K843748 |
510k Number | K843748 |
Device Name: | ANTI-ASPIRATION VALVE |
Classification | Set, Administration, Intravascular |
Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Patricia S Barsanti |
Correspondent | Patricia S Barsanti TRAVENOL LABORATORIES, S.A. 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 | 1984-09-25 |
Decision Date | 1985-01-03 |