The following data is part of a premarket notification filed by Surgidyne, Inc. with the FDA for Varidyne Model 250 Suction Drainage System.
| Device ID | K883582 |
| 510k Number | K883582 |
| Device Name: | VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | SURGIDYNE, INC. 9600 W. 76TH STREET, SUITE D Eden Prairie, MN 55344 |
| Contact | Mary M Maijer |
| Correspondent | Mary M Maijer SURGIDYNE, INC. 9600 W. 76TH STREET, SUITE D Eden Prairie, MN 55344 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-22 |
| Decision Date | 1988-10-03 |