The following data is part of a premarket notification filed by Invictus Medical, Inc. with the FDA for Invictus Medical Gelshield.
| Device ID | K150243 |
| 510k Number | K150243 |
| Device Name: | Invictus Medical GelShield |
| Classification | Protector, Skin Pressure |
| Applicant | Invictus Medical, Inc. 12500 Network Blvd., Suite 308 San Antonio, TX 78249 |
| Contact | Chris Gilmer |
| Correspondent | Scott Thiel Navigant Consulting 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268 |
| Product Code | FMP |
| CFR Regulation Number | 880.6450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-05-01 |
| Summary: | summary |