BACILLUS PUMILUS— 510(k) K780974
Substantially EquivalentUrol, Inc.
FDA 510(k) clearance K780974 for BACILLUS PUMILUS, Substantially Equivalent on 1978-07-27. Applicant: Urol, Inc.. Device class: 1.
Clearance details
- Applicant
- Urol, Inc.
- Product code
- Code FRL
- Device class
- Class 1
- Regulation
- 21 CFR 880.5300
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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