The following data is part of a premarket notification filed by Infant Advantage, Inc. with the FDA for Nature's Cradle Hm-10.
| Device ID | K921327 |
| 510k Number | K921327 |
| Device Name: | NATURE'S CRADLE HM-10 |
| Classification | Bed, Pediatric Open Hospital |
| Applicant | INFANT ADVANTAGE, INC. 361 SINCLAIR FRONTAGE RD. Milpitas, CA 95035 |
| Contact | James D Gatts |
| Correspondent | James D Gatts INFANT ADVANTAGE, INC. 361 SINCLAIR FRONTAGE RD. Milpitas, CA 95035 |
| Product Code | FMS |
| CFR Regulation Number | 880.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-18 |
| Decision Date | 1992-12-29 |