VISITEC NEEDLE RANGE (GASTERUROLOGY)
FDA 510(k) clearance K811965 · decided 1981-08-25
Clearance details
- K-number
- K811965
- Device name
- VISITEC NEEDLE RANGE (GASTERUROLOGY)
- Applicant
- Visitec Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-10
- Decision date
- 1981-08-25
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- FHR
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.