The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Vacpac Portable Aspiration System.
| Device ID | K910271 |
| 510k Number | K910271 |
| Device Name: | VACPAC PORTABLE ASPIRATION SYSTEM |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | JEDMED INSTRUMENT CO. 6096 LEMAY FERRY RD. St.louis, MO 63129 -2217 |
| Contact | Craig Rapp |
| Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 6096 LEMAY FERRY RD. St.louis, MO 63129 -2217 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-23 |
| Decision Date | 1991-03-20 |