The following data is part of a premarket notification filed by Realgrow Intl. Corp. with the FDA for Cooling Teethers.
| Device ID | K902974 |
| 510k Number | K902974 |
| Device Name: | COOLING TEETHERS |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | REALGROW INTL. CORP. 441 W. ALLEN AVE. UNIT #102 SAN DIMAS, CA 91773 |
| Contact | CINDY LEUNG |
| Correspondent | CINDY LEUNG REALGROW INTL. CORP. 441 W. ALLEN AVE. UNIT #102 SAN DIMAS, CA 91773 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-06 |
| Decision Date | 1991-04-03 |