SPECIMEN COLLECTION DEVICE— 510(k) K780049
Substantially EquivalentUrol, Inc.
FDA 510(k) clearance K780049 for SPECIMEN COLLECTION DEVICE, Substantially Equivalent on 1978-01-26. Applicant: Urol, Inc.. Device class: 1.
Clearance details
- Applicant
- Urol, Inc.
- Product code
- Code FMH
- Device class
- Class 1
- Regulation
- 21 CFR 864.3250
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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