OMNISONIC ENDOSCOPIC DEFLECTOR
FDA 510(k) clearance K993445 · decided 1999-12-06
Clearance details
- K-number
- K993445
- Device name
- OMNISONIC ENDOSCOPIC DEFLECTOR
- Applicant
- Omnisonics Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1999-10-12
- Decision date
- 1999-12-06
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- GCM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hopkonton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.