510(k) K062261
- Device
- FOAM RING PORT PROTECTOR
- Applicant
- INSPIRED IDEAS, INCORPORATED
- 510(k) number
- K062261
- Product code
- OBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-04-09
- Date received
- 2006-08-04
- Regulation
- 880.5965
- Classification name
- Port, Protector/cushion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Allison Scott
- Address
- 11460 N.Meridian St., Suite 150 Carmel IN US 46032 46032
Source Documents#
Legacy Summary#
summary
FDA Review#
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