The following data is part of a premarket notification filed by Arcon Corp. with the FDA for Mentor Plus (condom).
| Device ID | K874383 |
| 510k Number | K874383 |
| Device Name: | MENTOR PLUS (CONDOM) |
| Classification | Condom |
| Applicant | ARCON CORP. 1421 2ND. AVENUE NW. Stewartville, MN 55976 |
| Contact | Richard Fryar |
| Correspondent | Richard Fryar ARCON CORP. 1421 2ND. AVENUE NW. Stewartville, MN 55976 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-26 |
| Decision Date | 1988-03-07 |