EZ-ASSIST-FILL
FDA 510(k) clearance K121661 · decided 2012-12-27
Clearance details
- K-number
- K121661
- Device name
- EZ-ASSIST-FILL
- Applicant
- Assist Fill, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-06-05
- Decision date
- 2012-12-27
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- PCM
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.