The following data is part of a premarket notification filed by Custom Services Intl., Inc. with the FDA for Extrawear, Gentlemen's Choice.
| Device ID | K972428 |
| 510k Number | K972428 |
| Device Name: | EXTRAWEAR, GENTLEMEN'S CHOICE |
| Classification | Condom |
| Applicant | CUSTOM SERVICES INTL., INC. 3111 WEST POST RD. Las Vegas, NV 89118 |
| Contact | Lillie C Thomas |
| Correspondent | Lillie C Thomas CUSTOM SERVICES INTL., INC. 3111 WEST POST RD. Las Vegas, NV 89118 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-27 |
| Decision Date | 1997-08-25 |
| Summary: | summary |