The following data is part of a premarket notification filed by Neutrogena Corp. with the FDA for Neufinish Resurfacing Cream.
Device ID | K982577 |
510k Number | K982577 |
Device Name: | NEUFINISH RESURFACING CREAM |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | NEUTROGENA CORP. 5760 WEST 96TH ST. Los Angeles, CA 90045 -5544 |
Contact | Yohini Appa |
Correspondent | Yohini Appa NEUTROGENA CORP. 5760 WEST 96TH ST. Los Angeles, CA 90045 -5544 |
Product Code | MGQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-24 |
Decision Date | 1998-10-21 |
Summary: | summary |