The following data is part of a premarket notification filed by Fraser Harlake, Inc. with the FDA for Fraser Harlake Emerg. Care Suction Sys.
| Device ID | K841903 |
| 510k Number | K841903 |
| Device Name: | FRASER HARLAKE EMERG. CARE SUCTION SYS |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | FRASER HARLAKE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-07 |
| Decision Date | 1984-06-14 |