510(k) K833690
- Device
- COAXIAL BALLOON URETHRAL DILATOR
- Applicant
- AMERICAN EDWARDS LABORATORIES
- 510(k) number
- K833690
- Product code
- FAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-29
- Date received
- 1983-10-18
- Regulation
- 510(k) Premarket Notification
- Classification name
- Replacer, Urethral
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Gastroenterology/Urology
- Device class
- 3
- 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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