The following data is part of a premarket notification filed by Surgidyne, Inc. with the FDA for Surgidyne Varidyne, Model 140-2i & Model 140-2id.
| Device ID | K860030 |
| 510k Number | K860030 |
| Device Name: | SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | SURGIDYNE, INC. 9600 W. 76TH STREET, SUITE D Eden Prairie, MN 55344 |
| Contact | George L Carlson |
| Correspondent | George L Carlson 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 | 1986-01-06 |
| Decision Date | 1986-02-12 |