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 |