The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Symbiosis Monopolar Electrosurgical Roller Electrodes.
| Device ID | K953453 |
| 510k Number | K953453 |
| Device Name: | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Contact | John William Box |
| Correspondent | John William Box SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-19 |
| Decision Date | 1996-01-17 |