The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Blood Sampling Set.
| Device ID | K103165 |
| 510k Number | K103165 |
| Device Name: | BLOOD SAMPLING SET |
| Classification | Set, Administration, Intravascular |
| Applicant | ACACIA, INC. 785 CHALLENGER STREET Brea, CA 92821 |
| Contact | Fergie Ferguson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-10-27 |
| Decision Date | 2010-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816513023470 | K103165 | 000 |