The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Cell-mate(tm) Mass Cytology-cellular Retrieval Syst.
| Device ID | K934193 |
| 510k Number | K934193 |
| Device Name: | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Contact | Marti Dyck |
| Correspondent | Marti Dyck BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Product Code | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1993-11-19 |