INSTINCT; PLAIN, DOTTED, ULTRA THIN— 510(k) K132390
Substantially EquivalentProfilatex, S.A. DE C.V.
FDA 510(k) clearance K132390 for INSTINCT; PLAIN, DOTTED, ULTRA THIN, Substantially Equivalent on 2014-04-22. Applicant: Profilatex, S.A. DE C.V.. Device class: 2.
Clearance details
- Applicant
- Profilatex, S.A. DE C.V.
- Product code
- Code HIS
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Chalco, MX
Recent devices under product code HIS
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