SIGMOIDOSCOPE/ DISPOSABLE— 510(k) K761180
Substantially EquivalentSmithkline Diagnostics, Inc.
FDA 510(k) clearance K761180 for SIGMOIDOSCOPE/ DISPOSABLE, Substantially Equivalent on 1977-01-05. Applicant: Smithkline Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Smithkline Diagnostics, Inc.
- Product code
- Code FAM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Smithkline Diagnostics, Inc.
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