The following data is part of a premarket notification filed by Custom Services Intl., Inc. with the FDA for Olympus,jasmine,jimmy-o Raincoat,drink,ares,aphrodite,zeus,apollo,selfcare,careplus,titan.
| Device ID | K963322 |
| 510k Number | K963322 |
| Device Name: | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN |
| Classification | Condom With Nonoxynol-9 |
| Applicant | CUSTOM SERVICES INTL., INC. 3111 WEST POST RD. Las Vegas, NV 89118 |
| Contact | Lillie C Thomas, M.s. |
| Correspondent | Lillie C Thomas, M.s. CUSTOM SERVICES INTL., INC. 3111 WEST POST RD. Las Vegas, NV 89118 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1997-01-22 |