The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Acacias Pharm/pump.
Device ID | K912771 |
510k Number | K912771 |
Device Name: | ACACIAS PHARM/PUMP |
Classification | Set, I.v. Fluid Transfer |
Applicant | ACACIA, INC. P.O. BOX 1799 Ojai, CA 93023 |
Contact | James J Sullivan |
Correspondent | James J Sullivan ACACIA, INC. P.O. BOX 1799 Ojai, CA 93023 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-24 |
Decision Date | 1992-02-14 |