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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16936296700076 | K220576 | 000 |
| 16936296700069 | K220576 | 000 |
| 16936296700083 | K220576 | 000 |
| 16936296700090 | K220576 | 000 |
| 16936296700106 | K220576 | 000 |
| 16936296700113 | K220576 | 000 |
| 16936296700014 | K220576 | 000 |
| 16936296700021 | K220576 | 000 |
| 16936296700038 | K220576 | 000 |
| 16936296700045 | K220576 | 000 |
| 16936296700052 | K220576 | 000 |