The following data is part of a premarket notification filed by Global Protection Corp. with the FDA for Latex Condom And Latex Condom Lubricated With Nonoxynol-9.
| Device ID | K024324 |
| 510k Number | K024324 |
| Device Name: | LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 |
| Classification | Condom |
| Applicant | GLOBAL PROTECTION CORP. 12 CHANNEL ST. Boston, MA 02210 |
| Contact | Davin T Wedel |
| Correspondent | Davin T Wedel GLOBAL PROTECTION CORP. 12 CHANNEL ST. Boston, MA 02210 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-26 |
| Decision Date | 2003-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002174908 | K024324 | 000 |
| 00850002174144 | K024324 | 000 |
| 00850002174366 | K024324 | 000 |
| 00850002174427 | K024324 | 000 |
| 00850002174571 | K024324 | 000 |
| 00850002174588 | K024324 | 000 |
| 00850002174595 | K024324 | 000 |
| 00850002174656 | K024324 | 000 |
| 00850002174717 | K024324 | 000 |
| 00850002174724 | K024324 | 000 |
| 00850002174731 | K024324 | 000 |
| 00850002174748 | K024324 | 000 |
| 00850002174755 | K024324 | 000 |
| 00850002174762 | K024324 | 000 |
| 00850002174823 | K024324 | 000 |
| 00850002174090 | K024324 | 000 |