510(k) K771066
- Device
- CATHETER, SAMPLING, CONDUIT
- Applicant
- MENTOR CORP.
- 510(k) number
- K771066
- Product code
- FEZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-11
- Date received
- 1977-06-13
- Regulation
- 876.5090
- Classification name
- Catheter And Tube, Suprapubic
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2243072
- 2618282
- 1423507
- 1319639
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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