The following data is part of a premarket notification filed by Janco Consulting Services with the FDA for Mc Infant Care Unie #pp30.
| Device ID | K950059 |
| 510k Number | K950059 |
| Device Name: | MC INFANT CARE UNIE #PP30 |
| Classification | Bed, Pediatric Open Hospital |
| Applicant | JANCO CONSULTING SERVICES 6839 MONTEVIDEO ROAD MISSISSAUGA, ONTARIO L5n 1n7 Canada, CA L5n 1n7 |
| Contact | Janet C Shaw |
| Correspondent | Janet C Shaw JANCO CONSULTING SERVICES 6839 MONTEVIDEO ROAD MISSISSAUGA, ONTARIO L5n 1n7 Canada, CA L5n 1n7 |
| Product Code | FMS |
| CFR Regulation Number | 880.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-06 |
| Decision Date | 1995-02-10 |