The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Derma Prene.
Device ID | K820665 |
510k Number | K820665 |
Device Name: | DERMA PRENE |
Classification | Surgeon's Gloves |
Applicant | ANSELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-11 |
Decision Date | 1982-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DERMA PRENE 73397001 1275979 Live/Registered |
Ansell Incorporated 1982-09-30 |