The following data is part of a premarket notification filed by Prugen Ip Holdings, Inc with the FDA for Emulsion Sb.
Device ID | K110732 |
510k Number | K110732 |
Device Name: | EMULSION SB |
Classification | Dressing, Wound, Drug |
Applicant | PRUGEN IP HOLDINGS, INC 8711 E PINNACLE PEAK ROAD SUITE C-201, PMB 225 Scottsdale, AZ 85255 |
Contact | Robert L Knechtel |
Correspondent | Robert L Knechtel PRUGEN IP HOLDINGS, INC 8711 E PINNACLE PEAK ROAD SUITE C-201, PMB 225 Scottsdale, AZ 85255 |
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 | 2011-03-16 |
Decision Date | 2011-06-03 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EMULSION SB 85765874 4625458 Live/Registered |
PRUGEN, LLC 2012-10-29 |