The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Mega-brush, Endoscopic Mass Cytology - Celluar Retrieval System.
| Device ID | K944614 |
| 510k Number | K944614 |
| Device Name: | MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM |
| Classification | Endoscopic Cytology Brush |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Contact | Martin Dyck |
| Correspondent | Martin Dyck BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-20 |
| Decision Date | 1995-04-05 |