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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741078054 | K951260 | 000 |
| 10801741077934 | K951260 | 000 |
| 10801741077941 | K951260 | 000 |
| 10801741077958 | K951260 | 000 |
| 10801741077965 | K951260 | 000 |
| 10801741077972 | K951260 | 000 |
| 10801741077989 | K951260 | 000 |
| 10801741077996 | K951260 | 000 |
| 10801741078009 | K951260 | 000 |
| 10801741078016 | K951260 | 000 |
| 10801741078023 | K951260 | 000 |
| 10801741078030 | K951260 | 000 |
| 10801741078047 | K951260 | 000 |
| 10801741077927 | K951260 | 000 |