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 |