SB Soft Hood - Straight type, SB Soft Hood - Undercut type
FDA 510(k) clearance K173004 · decided 2018-05-08
Clearance details
- K-number
- K173004
- Device name
- SB Soft Hood - Straight type, SB Soft Hood - Undercut type
- Applicant
- Sumitomo Bakelite Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-27
- Decision date
- 2018-05-08
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Shinagawa-Ku, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.