The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Cell Recovery System.
| Device ID | K960004 |
| 510k Number | K960004 |
| Device Name: | CELL RECOVERY SYSTEM |
| Classification | Endoscopic Cytology Brush |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 9191 TOWNE CENTRE DR., #420 San Diego, CA 92122 |
| Contact | M. Lee Hulsebus |
| Correspondent | M. Lee Hulsebus MEDICAL DEVICE TECHNOLOGIES, INC. 9191 TOWNE CENTRE DR., #420 San Diego, CA 92122 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-03-20 |
| Summary: | summary |