The following data is part of a premarket notification filed by Lamtic, Inc. with the FDA for Accu-drop I.v. Extension Set.
Device ID | K923560 |
510k Number | K923560 |
Device Name: | ACCU-DROP I.V. EXTENSION SET |
Classification | Set, Administration, Intravascular |
Applicant | LAMTIC, INC. 18 TECHNOLOGY DR., SUITE 138 Irvine, CA 92718 |
Contact | Alfred M Wu |
Correspondent | Alfred M Wu LAMTIC, INC. 18 TECHNOLOGY DR., SUITE 138 Irvine, CA 92718 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-17 |
Decision Date | 1993-06-17 |