MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE
FDA 510(k) clearance K950966 · decided 1995-07-26
Clearance details
- K-number
- K950966
- Device name
- MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE
- Applicant
- Medical Advances, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-02
- Decision date
- 1995-07-26
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.