510(k) K811851
- Device
- S-610 SHUNT ADAPTOR SET
- Applicant
- DRAVON MEDICAL, INC.
- 510(k) number
- K811851
- Product code
- KNR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-08-31
- Date received
- 1981-07-01
- Regulation
- 876.5540
- Classification name
- Adapter, A-v Shunt Or Fistula
- 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
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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