510(k) K052858
- Device
- SOOTHIES GEL PADS
- Applicant
- PURONXY, INC.
- 510(k) number
- K052858
- Product code
- NXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-02-09
- Date received
- 2005-10-11
- Regulation
- 880.5630
- Classification name
- Nursing Pad, Cohesive Gel
- 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
- LESLIE SEBASTAIN
- Address
- 9853 Pacific Heights Blvd. Suite L San Diego CA US 92121 92121
FDA Registration Numbers#
- 1643116
- 3018269545
- 3014205191
- 3029906449
- 3006015326
- 3010183315
- 3002907620
- 1217805
- 3015139841
- 1929833
- 3008808560
- 3013354376
- 1720929
- 3005031124
- 3015501220
Source Documents#
Legacy Summary#
summary
FDA Review#
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