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FDA 510(k), K120555, LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
FDA 510(k), K120555, LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
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510(K) Number: K120555
Device Name: LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
Manufacturer: UMA DEVI
Device Classification Name: Condom
Regulation Number: HIS
Classification Product Code: 02/23/2012
Date Received: 11/02/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
Manufacturer: UMA DEVI
Device Classification Name: Condom
Regulation Number: HIS
Classification Product Code: 02/23/2012
Date Received: 11/02/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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