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.
Device ID | K983320 |
510k Number | K983320 |
Device Name: | ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS |
Classification | Condom |
Applicant | SURETEX PROPHYLACTICS (INDIA) LTD. 74-91, KIADB INDUSTRIAL ESTATE JIGANI II PHASE,ANEKAL TALUK Bangalore, IN 562 106 |
Contact | V.v. Ramana Rao |
Correspondent | V.v. Ramana Rao SURETEX PROPHYLACTICS (INDIA) LTD. 74-91, KIADB INDUSTRIAL ESTATE JIGANI II PHASE,ANEKAL TALUK Bangalore, IN 562 106 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-21 |
Decision Date | 1998-12-11 |
Summary: | summary |