AEROETCHER
FDA 510(k) clearance K973679 · decided 1998-03-10
Clearance details
- K-number
- K973679
- Device name
- AEROETCHER
- Applicant
- Parkell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-26
- Decision date
- 1998-03-10
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- KOJ
- Device class
- 2
- Regulation number
- 872.6080
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Farmingdale, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.