The following data is part of a premarket notification filed by Daun International, Inc. with the FDA for Merivaara Crib Trolley-model 381.
| Device ID | K852173 |
| 510k Number | K852173 |
| Device Name: | MERIVAARA CRIB TROLLEY-MODEL 381 |
| Classification | Bed, Pediatric Open Hospital |
| Applicant | DAUN INTERNATIONAL, INC. 431 SOUTH DEARBORN ST., SU 705 Chicago, IL 60605 |
| Contact | Bradford J Perino |
| Correspondent | Bradford J Perino DAUN INTERNATIONAL, INC. 431 SOUTH DEARBORN ST., SU 705 Chicago, IL 60605 |
| Product Code | FMS |
| CFR Regulation Number | 880.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-06-17 |