The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Tandem Sets I.v..
| Device ID | K850757 |
| 510k Number | K850757 |
| Device Name: | TANDEM SETS I.V. |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | ACACIA, INC. P.O. BOX 1240 Loma Linda, CA 92354 |
| Contact | James J Sullivan |
| Correspondent | James J Sullivan ACACIA, INC. P.O. BOX 1240 Loma Linda, CA 92354 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816513022657 | K850757 | 000 |
| 00858641006017 | K850757 | 000 |
| 00816513020011 | K850757 | 000 |
| 00816513020028 | K850757 | 000 |
| 00816513020035 | K850757 | 000 |
| 00816513020042 | K850757 | 000 |
| 00816513020059 | K850757 | 000 |
| 00816513020066 | K850757 | 000 |
| 00816513020189 | K850757 | 000 |
| 00816513020257 | K850757 | 000 |
| 00816513020271 | K850757 | 000 |
| 00816513022091 | K850757 | 000 |
| 00816513022480 | K850757 | 000 |
| 00816513022640 | K850757 | 000 |
| 00858641006000 | K850757 | 000 |