The following data is part of a premarket notification filed by Exelint Intl. Co. with the FDA for Exel I.v. Administration Set.
Device ID | K010404 |
510k Number | K010404 |
Device Name: | EXEL I.V. ADMINISTRATION SET |
Classification | Set, Administration, Intravascular |
Applicant | EXELINT INTL. CO. P.O. BOX 3194 Culver City, CA 90231 -3194 |
Contact | Armand Hamid |
Correspondent | Armand Hamid EXELINT INTL. CO. 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 | 2001-02-12 |
Decision Date | 2001-08-30 |