The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Biogel Pi Micro Indicator Underglove.
| Device ID | K150146 |
| 510k Number | K150146 |
| Device Name: | Biogel PI Micro Indicator Underglove |
| Classification | Surgeon's Gloves |
| Applicant | MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill 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 | 2015-01-22 |
| Decision Date | 2015-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190084838 | K150146 | 000 |
| 07323190084807 | K150146 | 000 |
| 07323190084760 | K150146 | 000 |
| 07323190084715 | K150146 | 000 |
| 07323190084685 | K150146 | 000 |
| 07323190084647 | K150146 | 000 |
| 07323190084593 | K150146 | 000 |
| 07323190084562 | K150146 | 000 |