510(k) K972383
- Device
- EASY-JET DEVICE
- Applicant
- A. STEIN - REGULATORY AFFAIRS CONSULTING
- 510(k) number
- K972383
- Product code
- KLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-11-23
- Date received
- 1997-06-26
- Regulation
- 874.3850
- Classification name
- Tube, Shunt, Endolymphatic With Valve
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- AHAVA STEIN
- Address
- P.O.B. 454 Ginot Shomron 44853 IL 44853 44853
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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