The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Biogel Ps Surgical Glove Series, Biogel Skinsense Surgical Glove Series.
Device ID | K140477 |
510k Number | K140477 |
Device Name: | BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES |
Classification | Surgeon's Gloves |
Applicant | MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
Contact | Curtis D Truesdale |
Correspondent | Curtis D Truesdale 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 | 2014-02-26 |
Decision Date | 2015-03-23 |
Summary: | summary |