The following data is part of a premarket notification filed by Johnson & Johnson Medical, Div. Of Ethicon, Inc. with the FDA for Tielle Plus Hydropolymer Adhesive Dressing.
| Device ID | K983234 |
| 510k Number | K983234 |
| Device Name: | TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington, TX 76014 -3631 |
| Contact | Terry J Dagnon |
| Correspondent | Terry J Dagnon JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington, TX 76014 -3631 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-15 |
| Decision Date | 1998-11-25 |
| Summary: | summary |