The following data is part of a premarket notification filed by Nitto Denko Technical Corp. with the FDA for Perme-aid Transparent Dressing, #11xx.
| Device ID | K884791 |
| 510k Number | K884791 |
| Device Name: | PERME-AID TRANSPARENT DRESSING, #11XX |
| Classification | Dressing, Wound, Drug |
| Applicant | NITTO DENKO TECHNICAL CORP. 2910 CORVIN DR. Santa Clara, CA 95051 |
| Contact | Mark Tsuji |
| Correspondent | Mark Tsuji NITTO DENKO TECHNICAL CORP. 2910 CORVIN DR. Santa Clara, CA 95051 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-15 |
| Decision Date | 1989-05-04 |