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 |
18859798100497 | 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 |
18859798101562 | K001883 | 000 |