The following data is part of a premarket notification filed by Molnlycke Health Care Usa with the FDA for Biogel Orthopro Indicator Underglove.
| Device ID | K101163 |
| 510k Number | K101163 |
| Device Name: | BIOGEL ORTHOPRO INDICATOR UNDERGLOVE |
| Classification | Surgeon's Gloves |
| Applicant | MOLNLYCKE HEALTH CARE USA 5550 PEACHTREE PKWY., STE. 500 Norcross, GA 30092 |
| Contact | Angela Bunn |
| Correspondent | Angela Bunn MOLNLYCKE HEALTH CARE USA 5550 PEACHTREE PKWY., STE. 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 | 2010-04-26 |
| Decision Date | 2010-11-23 |
| Summary: | summary |