The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Symbiosis Monoplar Electrosurgical Electrodes.
| Device ID | K953242 |
| 510k Number | K953242 |
| Device Name: | SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Contact | John W Box |
| Correspondent | John W Box SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Product Code | KNF |
| Subsequent Product Code | FAS |
| Subsequent Product Code | HIH |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-11 |
| Decision Date | 1995-10-06 |