SINUFLUSH LAVAGE SYSTEM— 510(k) K131177
Substantially EquivalentHedgepath, LLC
FDA 510(k) clearance K131177 for SINUFLUSH LAVAGE SYSTEM, Substantially Equivalent on 2013-09-20. Applicant: Hedgepath, LLC. Device class: 1.
Clearance details
- Applicant
- Hedgepath, LLC
- Product code
- Code KAR
- Device class
- Class 1
- Regulation
- 21 CFR 874.4420
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampa, FL, US
Recent devices under product code KAR
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