The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for Tielle* Hydropolymer Dressing.
| Device ID | K946245 |
| 510k Number | K946245 |
| Device Name: | TIELLE* HYDROPOLYMER DRESSING |
| Classification | Bandage, Liquid |
| Applicant | JOHNSON & JOHNSON INTERNATIONAL P.O. BOX 90130 2500 ARBROOK BLVD. Arlington, TX 76004 |
| Contact | Ralph H Larsen |
| Correspondent | Ralph H Larsen JOHNSON & JOHNSON INTERNATIONAL P.O. BOX 90130 2500 ARBROOK BLVD. Arlington, TX 76004 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-22 |
| Decision Date | 1995-04-11 |