The following data is part of a premarket notification filed by Apex Medical, Inc. with the FDA for Apex Alpha Vacuum Pump.
| Device ID | K871570 |
| 510k Number | K871570 |
| Device Name: | APEX ALPHA VACUUM PUMP |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | APEX MEDICAL, INC. 990 DILLMAN RD. Martinsville, IN 46151 |
| Contact | Larry Inman |
| Correspondent | Larry Inman APEX MEDICAL, INC. 990 DILLMAN RD. Martinsville, IN 46151 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-22 |
| Decision Date | 1987-08-18 |