S
SutureOut
I'm wondering if anyone can provide some clarity on requirements for a 510k exempt Class I device - a suture removal kit.
I need to know if the following are required for a device of this class:
- Shelf Life testing
- Sterility
- Certificate of Analysis
- Biocompatibility Testing
Thank you,
Rishi
I need to know if the following are required for a device of this class:
- Shelf Life testing
- Sterility
- Certificate of Analysis
- Biocompatibility Testing
Thank you,
Rishi