The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for Bioclusive(r) Absorbent Dressing.
| Device ID | K896828 |
| 510k Number | K896828 |
| Device Name: | BIOCLUSIVE(R) ABSORBENT DRESSING |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| Applicant | JOHNSON & JOHNSON INTERNATIONAL 410 GEORGE ST. New Brunswick, NJ 08901 |
| Contact | James E Mccann |
| Correspondent | James E Mccann JOHNSON & JOHNSON INTERNATIONAL 410 GEORGE ST. New Brunswick, NJ 08901 |
| Product Code | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-04 |
| Decision Date | 1990-11-21 |