SEDRATROL— 510(k) K940430
Substantially EquivalentMedical Specialties Intl., Inc.
FDA 510(k) clearance K940430 for SEDRATROL, Substantially Equivalent on 1995-02-06. Applicant: Medical Specialties Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Specialties Intl., Inc.
- Product code
- Code GJR
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Plainfield, NJ, US
Recent devices under product code GJR
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