The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for Barrier Saf-te Hydrogel Drape.
| Device ID | K922918 |
| 510k Number | K922918 |
| Device Name: | BARRIER SAF-TE HYDROGEL DRAPE |
| Classification | Drape, Surgical |
| Applicant | JOHNSON & JOHNSON INTERNATIONAL P.O. BOX 90130 2500 ARBROOK BLVD. Arlington, TX 76004 |
| Contact | T. M Wendt |
| Correspondent | T. M Wendt JOHNSON & JOHNSON INTERNATIONAL P.O. BOX 90130 2500 ARBROOK BLVD. Arlington, TX 76004 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-18 |
| Decision Date | 1993-07-06 |