The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Prophylactic (condom) Mr. Johnny.
| Device ID | K865106 |
| 510k Number | K865106 |
| Device Name: | PROPHYLACTIC (CONDOM) MR. JOHNNY |
| Classification | Condom |
| Applicant | MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Contact | Docal, M.d. |
| Correspondent | Docal, M.d. MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-31 |
| Decision Date | 1987-05-20 |