The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Symbiosis Monopolar Electrosurgical Roller Electrodes.
| Device ID | K955119 |
| 510k Number | K955119 |
| Device Name: | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES |
| Classification | Hysteroscope (and Accessories) |
| Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Contact | James R Stitt |
| Correspondent | James R Stitt SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-09 |
| Decision Date | 1996-01-18 |