MODULAR PORP AND TORP MODEL TBD— 510(k) K002378
Substantially EquivalentGyrus Ent LLC
FDA 510(k) clearance K002378 for MODULAR PORP AND TORP MODEL TBD, Substantially Equivalent on 2000-08-29. Applicant: Gyrus Ent LLC. Device class: 2.
Clearance details
- Applicant
- Gyrus Ent LLC
- Product code
- Code ETA
- Device class
- Class 2
- Regulation
- 21 CFR 874.3495
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.