Interlude 100% Cotton Tampon

Tampon, Menstrual, Unscented

ALBAAD Fem

The following data is part of a premarket notification filed by Albaad Fem with the FDA for Interlude 100% Cotton Tampon.

Pre-market Notification Details

Device IDK181911
510k NumberK181911
Device Name:Interlude 100% Cotton Tampon
ClassificationTampon, Menstrual, Unscented
Applicant ALBAAD Fem 1, Alon Hatavor St. Caesarea Ind. Park,  IL 3088900
ContactShlomo Helvits
CorrespondentRobert J. Staab
Regulatory Technical Associates 30 Neck Road Old Lyme,  CT  06371
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-17
Decision Date2018-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810027130167 K181911 000
00810027130150 K181911 000

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