| Device Classification Name |
Bed, Pediatric Open Hospital
|
| 510(k) Number |
K970334 |
| Device Name |
NATURE'S CRADLE |
| Applicant |
| Infant Advantage, Inc. |
| 2000 Crow Canyon Pl., |
| Suite 185 |
|
San Ramon,
CA
94583
|
|
| Applicant Contact |
GERALD V BEEMILLER |
| Correspondent |
| Infant Advantage, Inc. |
| 2000 Crow Canyon Pl., |
| Suite 185 |
|
San Ramon,
CA
94583
|
|
| Correspondent Contact |
GERALD V BEEMILLER |
| Regulation Number | 880.5140 |
| Classification Product Code |
|
| Date Received | 01/28/1997 |
| Decision Date | 04/25/1997 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|