The following data is part of a premarket notification filed by Shanghai Latex Factory with the FDA for Tulip Condom.
| Device ID | K050360 |
| 510k Number | K050360 |
| Device Name: | TULIP CONDOM |
| Classification | Condom |
| Applicant | SHANGHAI LATEX FACTORY 1700 HUANG XING ROAD Shanghai, CN 200433 |
| Contact | Lou Ji |
| Correspondent | Laura L Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-14 |
| Decision Date | 2005-03-01 |
| Summary: | summary |