The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Lifestyles Xtra Pleasure.
Device ID | K983518 |
510k Number | K983518 |
Device Name: | LIFESTYLES XTRA PLEASURE |
Classification | Condom |
Applicant | ANSELL, INC. 1500 INDUSTRIAL RD. Dothan, AL 36303 |
Contact | Lon Mcilvain |
Correspondent | Lon Mcilvain ANSELL, INC. 1500 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 | 1998-10-07 |
Decision Date | 1999-07-06 |
Summary: | summary |