510(k) K811965
- Device
- VISITEC NEEDLE RANGE (GASTERUROLOGY)
- Applicant
- VISITEC CO.
- 510(k) number
- K811965
- Product code
- FHR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-08-25
- Date received
- 1981-07-10
- Regulation
- 878.4800
- Classification name
- Needle, Gastro-urology
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 9611112
- 1932180
- 3005440795
- 2135225
- 1825146
- 3013840437
- 8010372
- 3012267976
- 9611102
- 1224960
- 1836161
- 8040278
- 3002647932
- 9611610
- 3003807268
- 1923569
- 9680515
- 3007597038
- 3001644167
- 1820334
- 1421101
- 8039051
- 1313525
- 8030607
- 1422634
- 3004361445
- 2531475
- 3006897996
- 3010966701
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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