KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED— 510(k) K113686
Substantially EquivalentMayer Laboratories, Inc.
FDA 510(k) clearance K113686 for KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED, Substantially Equivalent on 2012-03-06. Applicant: Mayer Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Mayer Laboratories, Inc.
- 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
- Berkely, CA, US
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