The following data is part of a premarket notification filed by Ansell Healthcare, Inc. with the FDA for Lifestyles Liquid Personal Lubricant.
| Device ID | K033076 |
| 510k Number | K033076 |
| Device Name: | LIFESTYLES LIQUID PERSONAL LUBRICANT |
| Classification | Condom |
| Applicant | ANSELL HEALTHCARE, INC. 1635 INDUSTRIAL RD. Dothan, AL 36303 |
| Contact | Lon D Mcilvain |
| Correspondent | Lon D Mcilvain ANSELL HEALTHCARE, INC. 1635 INDUSTRIAL RD. Dothan, AL 36303 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40024291290481 | K033076 | 000 |
| 10024291281419 | K033076 | 000 |
| 10024291281389 | K033076 | 000 |
| 10024291261015 | K033076 | 000 |
| 00024291290483 | K033076 | 000 |
| 00024291281412 | K033076 | 000 |
| 00024291281382 | K033076 | 000 |
| 00024291271925 | K033076 | 000 |
| 00024291262831 | K033076 | 000 |
| 00024291261018 | K033076 | 000 |
| 10024291261190 | K033076 | 000 |
| 00024291262824 | K033076 | 000 |
| 00024291261193 | K033076 | 000 |
| 20024291261012 | K033076 | 000 |
| 20024291261029 | K033076 | 000 |
| 30070907070001 | K033076 | 000 |
| 30024291290484 | K033076 | 000 |
| 20024291281416 | K033076 | 000 |
| 20024291281386 | K033076 | 000 |
| 20024291271929 | K033076 | 000 |
| 20024291262835 | K033076 | 000 |
| 20024291262828 | K033076 | 000 |
| 20024291262811 | K033076 | 000 |
| 20024291262804 | K033076 | 000 |
| 20024291261197 | K033076 | 000 |
| 20024291261043 | K033076 | 000 |
| 20024291261036 | K033076 | 000 |
| 18859798100329 | K033076 | 000 |