The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc with the FDA for Lifestyles Zero Lubricated Latex Male Condom.
| Device ID | K163107 |
| 510k Number | K163107 |
| Device Name: | Lifestyles Zero Lubricated Latex Male Condom |
| Classification | Condom |
| Applicant | ANSELL HEALTHCARE PRODUCTS, LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Contact | Robert Mahler |
| Correspondent | Robert Mahler ANSELL HEALTHCARE PRODUCTS, LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-07 |
| Decision Date | 2017-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30070907296371 | K163107 | 000 |
| 18859798101036 | K163107 | 000 |
| 18859798100985 | K163107 | 000 |
| 00070907207369 | K163107 | 000 |
| 00070907207376 | K163107 | 000 |
| 10070907000226 | K163107 | 000 |
| 80070907101106 | K163107 | 000 |
| 00070907000243 | K163107 | 000 |
| 80070907703164 | K163107 | 000 |
| 30070907202105 | K163107 | 000 |
| 30070907230078 | K163107 | 000 |
| 30070907230214 | K163107 | 000 |
| 30070907201795 | K163107 | 000 |
| 30070907220284 | K163107 | 000 |
| 30070907296364 | K163107 | 000 |
| 18859798101029 | K163107 | 000 |