The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Symbiosis Suction-irrigator.
| Device ID | K923563 |
| 510k Number | K923563 |
| Device Name: | SYMBIOSIS SUCTION-IRRIGATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Contact | Kevin W Smith |
| Correspondent | Kevin W Smith SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-17 |
| Decision Date | 1992-11-25 |