The following data is part of a premarket notification filed by Delta Enterprise Corporation with the FDA for Baby Snoopy Water Filled Teether, Model 95367.
| Device ID | K052513 |
| 510k Number | K052513 |
| Device Name: | BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | DELTA ENTERPRISE CORPORATION 17 STATE STREET, 19TH FLOOR New York, NY 10004 |
| Contact | Maria E Celis |
| Correspondent | Maria E Celis DELTA ENTERPRISE CORPORATION 17 STATE STREET, 19TH FLOOR New York, NY 10004 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-14 |
| Decision Date | 2006-06-28 |
| Summary: | summary |