The following data is part of a premarket notification filed by Suretex Prophylactics (india) Ltd. with the FDA for Various Ansell Tradenames Or Private Label.
| Device ID | K992081 |
| 510k Number | K992081 |
| Device Name: | VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL |
| Classification | Condom |
| Applicant | SURETEX PROPHYLACTICS (INDIA) LTD. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan, AL 36302 |
| Contact | Lon D Mcilvain |
| Correspondent | Lon D Mcilvain SURETEX PROPHYLACTICS (INDIA) LTD. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan, AL 36302 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-21 |
| Decision Date | 1999-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813356000231 | K992081 | 000 |
| 00850002174502 | K992081 | 000 |
| 00850002174014 | K992081 | 000 |
| 30070907062006 | K992081 | 000 |
| 18859798100091 | K992081 | 000 |