510(k) K172962
- Device
- Nurture Rest
- Applicant
- Neonatal Loving Kare, Inc.
- 510(k) number
- K172962
- Product code
- OUW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-18
- Date received
- 2017-09-26
- Regulation
- 880.5680
- Classification name
- Infant Positioner, Rx, Use In Highly Monitored Setting
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nicole Sawyers
- Address
- 1702 Treasure Lake Dubois PA US 15801 15801
Source Documents#
Legacy Summary#
summary
FDA Review#
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