The following data is part of a premarket notification filed by Molnlycke Health Care Us Llc. with the FDA for Biogel Skinsense Indicator Underglove, Biogel Pi Ultratouch, Biogel Pi Indicator Underglove, Biogel Pi, Biogel Pi Micro.
Device ID | K193573 |
510k Number | K193573 |
Device Name: | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro |
Classification | Surgeon's Gloves |
Applicant | Molnlycke Health Care US LLC. 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 |
Contact | Calen Souther |
Correspondent | Calen Souther Molnlycke Health Care US LLC. 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-23 |
Decision Date | 2020-04-10 |