The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Symbiosis Reusable Monopolar Electrosurgical Probe.
| Device ID | K941426 |
| 510k Number | K941426 |
| Device Name: | SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Contact | Kevin Smith |
| Correspondent | Kevin 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 | 1994-03-24 |
| Decision Date | 1994-06-22 |