The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel I.v. Administration Set.
Device ID | K963659 |
510k Number | K963659 |
Device Name: | EXEL I.V. ADMINISTRATION SET |
Classification | Set, Administration, Intravascular |
Applicant | EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
Contact | Armand Hamid |
Correspondent | Armand Hamid EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-03 |
Decision Date | 1997-12-16 |