The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for Biogel Pl Micro Surgical Glove.
Device ID | K141719 |
510k Number | K141719 |
Device Name: | BIOGEL PL MICRO SURGICAL GLOVE |
Classification | Surgeon's Gloves |
Applicant | MOLNLYCKE HEALTH CARE, US LLC 5550 PEACHTREE PARKWAY, SUITE 500 Norcross, GA 30092 |
Contact | Curtis Truesdale |
Correspondent | Curtis 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-25 |
Decision Date | 2014-09-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07323190070787 | K141719 | 000 |
07323190070732 | K141719 | 000 |
07323190070947 | K141719 | 000 |
07323190070701 | K141719 | 000 |
07323190070985 | K141719 | 000 |
07323190070862 | K141719 | 000 |
07323190070909 | K141719 | 000 |
07323190070664 | K141719 | 000 |