The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Urinary Intermittent Catheters W/o Hydromer Hydrophilic Lubricant.
| Device ID | K951260 |
| 510k Number | K951260 |
| Device Name: | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT |
| Classification | Catheter, Urological |
| 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 | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-21 |
| Decision Date | 1995-09-27 |