The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Gastro Enterological Bioptome.
| Device ID | K894419 |
| 510k Number | K894419 |
| Device Name: | GASTRO ENTEROLOGICAL BIOPTOME |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-09-08 |