The following data is part of a premarket notification filed by Mapa Gmbh with the FDA for Billy Boy Male Latex Condom.
| Device ID | K111093 |
| 510k Number | K111093 |
| Device Name: | BILLY BOY MALE LATEX CONDOM |
| Classification | Condom |
| Applicant | MAPA GMBH INDUSTRIESTRASSE 21-25 Zeven, DE 27404 |
| Contact | German Frank |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-19 |
| Decision Date | 2011-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002174540 | K111093 | 000 |
| 00850002174533 | K111093 | 000 |