The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Cell Recovery System.
| Device ID | K965037 |
| 510k Number | K965037 |
| Device Name: | CELL RECOVERY SYSTEM |
| Classification | Endoscopic Cytology Brush |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 9171 TOWNE CENTRE DR., #355 San Diego, CA 92122 |
| Contact | Richard E Sloan |
| Correspondent | Richard E Sloan MEDICAL DEVICE TECHNOLOGIES, INC. 9171 TOWNE CENTRE DR., #355 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 | 1996-12-17 |
| Decision Date | 1997-01-08 |
| Summary: | summary |