The following data is part of a premarket notification filed by Shanghai Personage Hygiene Products Co.,ltd. with the FDA for Fama Male Latex Condoms.
Device ID | K220576 |
510k Number | K220576 |
Device Name: | FAMA Male Latex Condoms |
Classification | Condom |
Applicant | Shanghai Personage Hygiene Products Co.,Ltd. 88 Tianchen Road Qingpu District, CN 201700 |
Contact | Haijiang Song |
Correspondent | Vincent Zhou Medwheat Inc. 7900 International Drive, Suite 300 Bloomington, MN 55425 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-28 |
Decision Date | 2022-08-05 |