ACU-SIZER(TM)
FDA 510(k) clearance K941011 · decided 1994-06-13
Clearance details
- K-number
- K941011
- Device name
- ACU-SIZER(TM)
- Applicant
- Applied Medical Resources
- Decision
- Substantially Equivalent
- Date received
- 1994-03-03
- Decision date
- 1994-06-13
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- EYB
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Launa Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.