EASY-JET DEVICE
FDA 510(k) clearance K972383 · decided 1999-11-23
Clearance details
- K-number
- K972383
- Device name
- EASY-JET DEVICE
- Applicant
- A.Stein - Regulatory Affairs Consulting
- Decision
- Substantially Equivalent
- Date received
- 1997-06-26
- Decision date
- 1999-11-23
- Days to decision
- 880 days
- Clearance type
- Traditional
- Product code
- KLZ
- Device class
- 2
- Regulation number
- 874.3850
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Ginot Shomron 44853, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.