The following data is part of a premarket notification filed by Richter Rubber Technology Sbn Bhd with the FDA for Richter Male Latex Condom.
| Device ID | K070511 |
| 510k Number | K070511 |
| Device Name: | RICHTER MALE LATEX CONDOM |
| Classification | Condom |
| Applicant | RICHTER RUBBER TECHNOLOGY SBN BHD PO BOX 12139 Durham, NC 27709 |
| Contact | Subramaniam Narayanasamy |
| Correspondent | Subramaniam Narayanasamy RICHTER RUBBER TECHNOLOGY SBN BHD PO BOX 12139 Durham, NC 27709 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-22 |
| Decision Date | 2008-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09556807313863 | K070511 | 000 |
| 09556807304106 | K070511 | 000 |
| 09556807304083 | K070511 | 000 |
| 09556807402499 | K070511 | 000 |
| 09556807401553 | K070511 | 000 |
| 09556807401522 | K070511 | 000 |
| 09556807403304 | K070511 | 000 |
| 09556807342337 | K070511 | 000 |
| 09556807342306 | K070511 | 000 |
| 09556807322278 | K070511 | 000 |
| 09556807322247 | K070511 | 000 |
| 09556807500898 | K070511 | 000 |
| 09556807500874 | K070511 | 000 |
| 09556807500850 | K070511 | 000 |
| 09556807304120 | K070511 | 000 |
| 09556807304144 | K070511 | 000 |
| 09556807313849 | K070511 | 000 |
| 09556807313825 | K070511 | 000 |
| 09556807313801 | K070511 | 000 |
| 19556807313778 | K070511 | 000 |
| 09556807313948 | K070511 | 000 |
| 09556807313924 | K070511 | 000 |
| 09556807313900 | K070511 | 000 |
| 09556807313887 | K070511 | 000 |
| 09556807304243 | K070511 | 000 |
| 09556807304229 | K070511 | 000 |
| 09556807304205 | K070511 | 000 |
| 09556807304182 | K070511 | 000 |
| 09556807304168 | K070511 | 000 |
| 09556807501949 | K070511 | 000 |