Harmony Latex Dam, Harmony Non-Latex Dam

Barrier, Std, Oral Sex

Pamco Distributing Inc.

The following data is part of a premarket notification filed by Pamco Distributing Inc. with the FDA for Harmony Latex Dam, Harmony Non-latex Dam.

Pre-market Notification Details

Device IDK203727
510k NumberK203727
Device Name:Harmony Latex Dam, Harmony Non-Latex Dam
ClassificationBarrier, Std, Oral Sex
Applicant Pamco Distributing Inc. 231 Arnold Street Kitchener,  CA N2h 6e8
ContactAnnette Maclean
CorrespondentCatriona Boyd
Ironstone Product Development 250 Carlaw Avenue, Suite 108 Toronto,  CA M4m 3l1
Product CodeMSC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-21
Decision Date2021-08-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860003804537 K203727 000
00860003804520 K203727 000
00860003804513 K203727 000
00860003804544 K203727 000
00628347069810 K203727 000
00628347065881 K203727 000
00628347062729 K203727 000
00628347062774 K203727 000
00628347062736 K203727 000

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