The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Lifestyles Lubricated Polyisoprene Latex Male Condom.
| Device ID | K070800 |
| 510k Number | K070800 |
| Device Name: | LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM |
| Classification | Condom, Synthetic |
| Applicant | ANSELL HEALTHCARE PRODUCTS LLC 1635 INDUSTRIAL RD. Dothan, AL 36303 |
| Contact | Lon D Mcilvain |
| Correspondent | Lon D Mcilvain ANSELL HEALTHCARE PRODUCTS LLC 1635 INDUSTRIAL RD. Dothan, AL 36303 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-23 |
| Decision Date | 2008-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00070907299036 | K070800 | 000 |
| 00070907209394 | K070800 | 000 |
| 00070907209363 | K070800 | 000 |
| 00070907207376 | K070800 | 000 |
| 00070907207369 | K070800 | 000 |
| 00070907074039 | K070800 | 000 |
| 00070907073032 | K070800 | 000 |
| 30070907098012 | K070800 | 000 |
| 30070907078007 | K070800 | 000 |
| 00070907211014 | K070800 | 000 |
| 00070907254158 | K070800 | 000 |
| 00070907297391 | K070800 | 000 |
| 00070907275122 | K070800 | 000 |
| 00070907274125 | K070800 | 000 |
| 00070907273241 | K070800 | 000 |
| 00070907273128 | K070800 | 000 |
| 00070907271247 | K070800 | 000 |
| 00070907271100 | K070800 | 000 |
| 00070907271032 | K070800 | 000 |
| 10070907271114 | K070800 | 000 |