ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.— 510(k) K863122
Substantially EquivalentSurgicot, Inc.
FDA 510(k) clearance K863122 for ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP., Substantially Equivalent on 1986-12-17. Applicant: Surgicot, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgicot, 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
- Smithtown, NY, US
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