Need help cutting though bureaucratic red tape that won't let your company sell your device? Nu Device Consulting LLC can help. Whether your firm is in the US or not, we help get your medical device to market in the US and offer a range of services to handle your regulatory needs.
Services offered include:
- FDA 510(k) submissions (Class I and Class II)
- Labeling
- FDA Master Files
- US Agent services
- FDA Registration and Listing
- HCPCS Level II Coding verification and modification requests
- US State Medical Device manufacturer registration
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