FDA 510(k), K101098, REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
FDA 510(k), K101098, REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
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510(K) Number: K101098
Device Name: REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
Manufacturer: PATRICIA MILLER
Device Classification Name: Lubricant, Personal
Regulation Number: NUC
Classification Product Code: 04/20/2010
Date Received: 08/17/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
Manufacturer: PATRICIA MILLER
Device Classification Name: Lubricant, Personal
Regulation Number: NUC
Classification Product Code: 04/20/2010
Date Received: 08/17/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology