ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS

Condom

SURETEX PROPHYLACTICS (INDIA) LTD.

The following data is part of a premarket notification filed by Suretex Prophylactics (india) Ltd. with the FDA for Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors.

Pre-market Notification Details

Device IDK983320
510k NumberK983320
Device Name:ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
ClassificationCondom
Applicant SURETEX PROPHYLACTICS (INDIA) LTD. 74-91, KIADB INDUSTRIAL ESTATE JIGANI II PHASE,ANEKAL TALUK Bangalore,  IN 562 106
ContactV.v. Ramana Rao
CorrespondentV.v. Ramana Rao
SURETEX PROPHYLACTICS (INDIA) LTD. 74-91, KIADB INDUSTRIAL ESTATE JIGANI II PHASE,ANEKAL TALUK Bangalore,  IN 562 106
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-21
Decision Date1998-12-11
Summary:summary

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