The following data is part of a premarket notification filed by Suretex Prophylactics (india) Ltd. with the FDA for Royale Of Latex Condoms - Spermicidal Lubricant - Colored Or Assorted Colors.
| Device ID | K981621 |
| 510k Number | K981621 |
| Device Name: | ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS |
| Classification | Condom With Nonoxynol-9 |
| 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 | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-06 |
| Decision Date | 1998-06-19 |
| Summary: | summary |