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 |