CRYOLOCK— 510(k) K122982
Substantially EquivalentBiotech, Inc.
FDA 510(k) clearance K122982 for CRYOLOCK, Substantially Equivalent on 2014-01-09. Applicant: Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotech, Inc.
- Product code
- Code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.