The following data is part of a premarket notification filed by Johnson & Johnson Patient Care, Inc. with the FDA for Johnson & Johnson Tube Securement Device.
| Device ID | K895431 |
| 510k Number | K895431 |
| Device Name: | JOHNSON & JOHNSON TUBE SECUREMENT DEVICE |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | JOHNSON & JOHNSON PATIENT CARE, INC. 410 GEORGE ST. New Brunswick, NJ 08901 |
| Contact | Mc Cann |
| Correspondent | Mc Cann JOHNSON & JOHNSON PATIENT CARE, INC. 410 GEORGE ST. New Brunswick, NJ 08901 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-10-13 |