The following data is part of a premarket notification filed by Cavity Free Kids, Inc. with the FDA for Pedo Cush Pedo Cuddle.
| Device ID | K972446 |
| 510k Number | K972446 |
| Device Name: | PEDO CUSH PEDO CUDDLE |
| Classification | Restraint, Protective |
| Applicant | CAVITY FREE KIDS, INC. 1224 ARCADE ST. St. Paul, MN 55106 |
| Contact | Vacharee S Peterson |
| Correspondent | Vacharee S Peterson CAVITY FREE KIDS, INC. 1224 ARCADE ST. St. Paul, MN 55106 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-30 |
| Decision Date | 1997-11-13 |
| Summary: | summary |