The following data is part of a premarket notification filed by Surgidyne, Inc. with the FDA for Varidyne 550, Models 12e,12m,24e & 24m Suction Sys.
| Device ID | K864822 |
| 510k Number | K864822 |
| Device Name: | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS |
| Classification | Bag, Reservoir |
| Applicant | SURGIDYNE, INC. 9600 W. 76TH STREET, SUITE D Eden Prairie, MN 55344 |
| Contact | Jud Carlson |
| Correspondent | Jud Carlson SURGIDYNE, INC. 9600 W. 76TH STREET, SUITE D Eden Prairie, MN 55344 |
| Product Code | BTC |
| CFR Regulation Number | 868.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-01-15 |