The following data is part of a premarket notification filed by Surgidyne, Inc. with the FDA for Surgidyne Surgiflo C.w.s. Drain Products.
| Device ID | K850634 |
| 510k Number | K850634 |
| Device Name: | SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | SURGIDYNE, INC. 6975 WASHINGTON AVE. SUITE 200 Minneapolis, MN 55435 |
| Contact | Charles B Mcneil |
| Correspondent | Charles B Mcneil SURGIDYNE, INC. 6975 WASHINGTON AVE. SUITE 200 Minneapolis, MN 55435 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-06-28 |