NEUROTOLOGY DRAPE, MODEL TBD— 510(k) K002702
Substantially EquivalentGyrus Ent LLC
FDA 510(k) clearance K002702 for NEUROTOLOGY DRAPE, MODEL TBD, Substantially Equivalent on 2000-10-26. Applicant: Gyrus Ent LLC. Device class: 2.
Clearance details
- Applicant
- Gyrus Ent LLC
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- 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.