The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Biosearch Syring Flushing/cleaning Pump For Biosearch Endoscopic Instruments.
| Device ID | K964871 |
| 510k Number | K964871 |
| Device Name: | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. P.O. BOX 1700 35 INDUSTRIAL PARKWAY Somerville, NJ 08876 |
| Contact | Rolan Soubra |
| Correspondent | Rolan Soubra BIOSEARCH MEDICAL PRODUCTS, INC. P.O. BOX 1700 35 INDUSTRIAL PARKWAY Somerville, NJ 08876 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-05 |
| Decision Date | 1997-03-03 |
| Summary: | summary |