SERIM DISINTEK GTA 2.1%, MODEL: 5164— 510(k) K083295
Substantially EquivalentSerim Research Corp.
FDA 510(k) clearance K083295 for SERIM DISINTEK GTA 2.1%, MODEL: 5164, Substantially Equivalent on 2009-03-16. Applicant: Serim Research Corp.. Device class: 2.
Clearance details
- Applicant
- Serim Research Corp.
- Product code
- Code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
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