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 |