The following data is part of a premarket notification filed by Rex Medical, L.p. with the FDA for Rex Medical Aspiration Pump.
| Device ID | K173389 |
| 510k Number | K173389 |
| Device Name: | Rex Medical Aspiration Pump |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | Rex Medical, L.P. 555 E. North Ln. Suite 5035 Conshohocken, PA 19428 |
| Contact | Erich Bressler |
| Correspondent | Susan Goldstein-falk MDI Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-30 |
| Decision Date | 2018-01-30 |
| Summary: | summary |