The following data is part of a premarket notification filed by C.b. Fleet Co., Inc. with the FDA for Summer's Eve Lubricating Jelly.
| Device ID | K990597 |
| 510k Number | K990597 |
| Device Name: | SUMMER'S EVE LUBRICATING JELLY |
| Classification | Condom |
| Applicant | C.B. FLEET CO., INC. 1050 CONNECTICUT AVENUE N.W. Washington, DC 20036 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz C.B. FLEET CO., INC. 1050 CONNECTICUT AVENUE N.W. Washington, DC 20036 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-24 |
| Decision Date | 1999-07-19 |