The following data is part of a premarket notification filed by Axiom, Inc. with the FDA for Axiom Atraum Wound Drains.
| Device ID | K883887 |
| 510k Number | K883887 |
| Device Name: | AXIOM ATRAUM WOUND DRAINS |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | AXIOM, INC. 7625 ROSECRANS AVE. SUITE 29, P.O. BOX 1306 Paramount, CA 90723 |
| Contact | Roger Wood |
| Correspondent | Roger Wood AXIOM, INC. 7625 ROSECRANS AVE. SUITE 29, P.O. BOX 1306 Paramount, CA 90723 |
| Product Code | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1989-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M665100008AT3 | K883887 | 000 |
| M665100028AT3 | K883887 | 000 |
| M665100028ATS3 | K883887 | 000 |
| M665100028ATSC3 | K883887 | 000 |
| M665100032AT3 | K883887 | 000 |
| M665100032ATS3 | K883887 | 000 |
| M665100032ATSC3 | K883887 | 000 |
| M665100036AT3 | K883887 | 000 |
| M665100036ATS3 | K883887 | 000 |
| M665100036ATSC3 | K883887 | 000 |
| M665100036ATSP1 | K883887 | 000 |
| M665100040AT3 | K883887 | 000 |
| M665100040ATS3 | K883887 | 000 |
| M665100040ATSC3 | K883887 | 000 |
| M665111016AT3 | K883887 | 000 |
| M665111016ATS3 | K883887 | 000 |
| M665111016ATSC3 | K883887 | 000 |
| M665111120AT3 | K883887 | 000 |
| M665100024ATSC3 | K883887 | 000 |
| M665100024ATS3 | K883887 | 000 |
| M665100024AT3 | K883887 | 000 |
| M665100008ATS3 | K883887 | 000 |
| M665100008ATSC3 | K883887 | 000 |
| M665100010AT3 | K883887 | 000 |
| M665100010ATS3 | K883887 | 000 |
| M665100010ATSC3 | K883887 | 000 |
| M665100012AT3 | K883887 | 000 |
| M665100012ATS3 | K883887 | 000 |
| M665100012ATSC3 | K883887 | 000 |
| M665100014AT3 | K883887 | 000 |
| M665100014ATS3 | K883887 | 000 |
| M665100014ATSC3 | K883887 | 000 |
| M665100016AT3 | K883887 | 000 |
| M665100016ATS3 | K883887 | 000 |
| M665100016ATSC3 | K883887 | 000 |
| M665100020AT3 | K883887 | 000 |
| M665100020ATS3 | K883887 | 000 |
| M665100020ATSC3 | K883887 | 000 |
| M665111120ATS3 | K883887 | 000 |
| M665111120ATSC3 | K883887 | 000 |
| M6653631AT3 | K883887 | 000 |
| M6653640AT3 | K883887 | 000 |
| M6653640ATSP1 | K883887 | 000 |
| M6653640ATSR3 | K883887 | 000 |
| M6653641AT3 | K883887 | 000 |
| M6653642AT3 | K883887 | 000 |
| M6653643AT3 | K883887 | 000 |
| M6653643ATSP1 | K883887 | 000 |
| M6653645AT3 | K883887 | 000 |
| M665401AT3 | K883887 | 000 |
| M665403AT3 | K883887 | 000 |
| M665410AT3 | K883887 | 000 |
| M665412AT3 | K883887 | 000 |
| M665412ATSX1 | K883887 | 000 |
| M665410ATSX1 | K883887 | 000 |
| M665100028ATX1 | K883887 | 000 |
| M665100032ATX1 | K883887 | 000 |
| M6653626AT3 | K883887 | 000 |
| M6653621AT3 | K883887 | 000 |
| M6653603AT3 | K883887 | 000 |
| M665111124AT3 | K883887 | 000 |
| M665111124ATS3 | K883887 | 000 |
| M665111124ATSC3 | K883887 | 000 |
| M665111128AT3 | K883887 | 000 |
| M665111128ATS3 | K883887 | 000 |
| M665111128ATSC3 | K883887 | 000 |
| M665111132AT3 | K883887 | 000 |
| M665111132ATS3 | K883887 | 000 |
| M665111132ATSC3 | K883887 | 000 |
| M665111136AT3 | K883887 | 000 |
| M665111136ATS3 | K883887 | 000 |
| M665111136ATSC3 | K883887 | 000 |
| M665111140AT3 | K883887 | 000 |
| M665111140ATS3 | K883887 | 000 |
| M665111140ATSC3 | K883887 | 000 |
| M6653601AT3 | K883887 | 000 |
| M6653602AT3 | K883887 | 000 |
| M665111136ATSP1 | K883887 | 000 |