The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Heavy Duty (hd) Suction Units (w/cannulas).
| Device ID | K862569 |
| 510k Number | K862569 |
| Device Name: | HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS) |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Contact | Craig Rapp |
| Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-07 |
| Decision Date | 1986-08-14 |