PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR— 510(k) K994381
Substantially EquivalentRaven Biological Laboratories, Inc.
FDA 510(k) clearance K994381 for PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR, Substantially Equivalent on 2001-03-30. Applicant: Raven Biological Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Raven Biological Laboratories, Inc.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Omaha, NE, US
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