The following data is part of a premarket notification filed by Infant Advantage, Inc. with the FDA for Nature's Cradle(tm).
Device ID | K901763 |
510k Number | K901763 |
Device Name: | NATURE'S CRADLE(TM) |
Classification | Bed, Pediatric Open Hospital |
Applicant | INFANT ADVANTAGE, INC. 361 SINCLAIR FRONTAGE RD. Milpitas, CA 95035 |
Contact | Gerald V Beemiller |
Correspondent | Gerald V Beemiller 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 | 1990-04-18 |
Decision Date | 1991-03-22 |