ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
FDA 510(k) clearance K071903 · decided 2007-08-02
Clearance details
- K-number
- K071903
- Device name
- ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
- Applicant
- Vision-Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-10
- Decision date
- 2007-08-02
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- EOX
- Device class
- 2
- Regulation number
- 874.4710
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Ayer, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.