The following data is part of a premarket notification filed by Janco Consulting Services with the FDA for Mc Healthcare #ch31 Child's Crib.
Device ID | K950058 |
510k Number | K950058 |
Device Name: | MC HEALTHCARE #CH31 CHILD'S CRIB |
Classification | Bed, Pediatric Open Hospital |
Applicant | JANCO CONSULTING SERVICES 6839 MONTEVIDEO ROAD MISSISSAUGA, ONTARIO L5n 1n7 Canada, CA L5n 1n7 |
Contact | Janet Shaw |
Correspondent | Janet 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 |