The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Flow-eze Blunt Cannula (1999bc).
| Device ID | K972538 |
| 510k Number | K972538 |
| Device Name: | FLOW-EZE BLUNT CANNULA (1999BC) |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-08 |
| Decision Date | 1998-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816513020295 | K972538 | 000 |
| 00816513020141 | K972538 | 000 |
| 00858641006031 | K972538 | 000 |