CURELLE, PREFERRED CURELLE, CUTEQ 2.5— 510(k) K020628
Substantially EquivalentBioteque America, Inc.
FDA 510(k) clearance K020628 for CURELLE, PREFERRED CURELLE, CUTEQ 2.5, Substantially Equivalent on 2002-05-24. Applicant: Bioteque America, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioteque America, Inc.
- Product code
- Code HHK
- Device class
- Class 2
- Regulation
- 21 CFR 884.1175
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Langhorne, PA, US
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