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 |