The following data is part of a premarket notification filed by China National Medicines & Health Prod. I/e Corp. with the FDA for Tp And Design, Condom.
| Device ID | K902324 |
| 510k Number | K902324 |
| Device Name: | TP AND DESIGN, CONDOM |
| Classification | Condom |
| Applicant | CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. LACKENBACH SIEGEL MARZULLO ONE CHASE RD. PENTHOUSE SUITE Scarsdale, NY 10583 |
| Contact | Howard N Aronson |
| Correspondent | Howard N Aronson CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. LACKENBACH SIEGEL MARZULLO ONE CHASE RD. PENTHOUSE SUITE Scarsdale, NY 10583 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-24 |
| Decision Date | 1991-03-29 |