DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905
FDA 510(k) clearance K003710 · decided 2001-02-02
Clearance details
- K-number
- K003710
- Device name
- DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-01
- Decision date
- 2001-02-02
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FET
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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