The following data is part of a premarket notification filed by Ansell Healthcare, Inc. with the FDA for Lifestyles, Contempo Or Private Label Large Condom.
| Device ID | K001883 |
| 510k Number | K001883 |
| Device Name: | LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM |
| Classification | Condom |
| Applicant | ANSELL HEALTHCARE, INC. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan, AL 36302 |
| Contact | Lon D Mcilvain |
| Correspondent | Lon D Mcilvain ANSELL HEALTHCARE, INC. 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 | 2000-06-21 |
| Decision Date | 2000-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813356000187 | K001883 | 000 |
| 18859798100084 | K001883 | 000 |
| 30070907098012 | K001883 | 000 |
| 00070907298107 | K001883 | 000 |
| 00792554643016 | K001883 | 000 |
| 00792554903028 | K001883 | 000 |
| 10070907000356 | K001883 | 000 |
| 10070907202125 | K001883 | 000 |
| 30070907230085 | K001883 | 000 |
| 30070907298580 | K001883 | 000 |
| 30070907230412 | K001883 | 000 |
| 30070907230429 | K001883 | 000 |
| 30070907098005 | K001883 | 000 |
| 00850002174489 | K001883 | 000 |
| 00850002174496 | K001883 | 000 |
| 00070907098035 | K001883 | 000 |
| 00070907270981 | K001883 | 000 |
| 18859798100497 | K001883 | 000 |