The following data is part of a premarket notification filed by Sheila Pickering Ph.d. with the FDA for Billy Boy Male Latex Condom.
| Device ID | K103119 |
| 510k Number | K103119 |
| Device Name: | BILLY BOY MALE LATEX CONDOM |
| Classification | Condom |
| Applicant | SHEILA PICKERING PH.D. 2061 LONGDEN CIRCLE Los Altos, CA 94024 |
| Contact | Sheila W Pickering |
| 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 | 2010-10-22 |
| Decision Date | 2011-02-24 |
| Summary: | summary |