510(k) K070163
- Device
- SWABBABLE CAP, MODEL 60205
- Applicant
- BAXA CORP.
- 510(k) number
- K070163
- Product code
- ODI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-08-03
- Date received
- 2007-01-17
- Regulation
- 880.5440
- Classification name
- Administration Set Docking Station
- 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
- KIMBERLY ZIZIK
- Address
- 14445 Grasslands Dr. Englewood CO US 80112 80112
Source Documents#
Legacy Summary#
summary
FDA Review#
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