The following data is part of a premarket notification filed by Corium Corp. with the FDA for Water Filled Gum Soother.
| Device ID | K981202 |
| 510k Number | K981202 |
| Device Name: | WATER FILLED GUM SOOTHER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | CORIUM CORP. P.O. BOX 4084 Monroe, LA 71211 |
| Contact | Joseph Hakim |
| Correspondent | Joseph Hakim CORIUM CORP. P.O. BOX 4084 Monroe, LA 71211 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1998-06-16 |