The following data is part of a premarket notification filed by Apollo Enterprise, Ltd. Co. with the FDA for Apollo Condom.
| Device ID | K874236 |
| 510k Number | K874236 |
| Device Name: | APOLLO CONDOM |
| Classification | Condom |
| Applicant | APOLLO ENTERPRISE, LTD. CO. 1395 N.W. 167 ST., STE. 103 Miami, FL 33169 |
| Contact | Howard Dollinger,dds |
| Correspondent | Howard Dollinger,dds APOLLO ENTERPRISE, LTD. CO. 1395 N.W. 167 ST., STE. 103 Miami, FL 33169 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-15 |
| Decision Date | 1988-07-01 |