The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Instrument, Manual, General Surgical.
| Device ID | K922571 |
| 510k Number | K922571 |
| Device Name: | INSTRUMENT, MANUAL, GENERAL SURGICAL |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-01 |
| Decision Date | 1992-08-11 |