The following data is part of a premarket notification filed by Intl. Management Services, Inc. with the FDA for Imsi/easy Float Mattress.
Device ID | K872876 |
510k Number | K872876 |
Device Name: | IMSI/EASY FLOAT MATTRESS |
Classification | Mattress, Water, Temperature Regulated |
Applicant | INTL. MANAGEMENT SERVICES, INC. 941 'O'STREET, SUITE 325 Lincoln, NE 68508 |
Contact | Patricia J Kuehl |
Correspondent | Patricia J Kuehl INTL. MANAGEMENT SERVICES, INC. 941 'O'STREET, SUITE 325 Lincoln, NE 68508 |
Product Code | FOH |
CFR Regulation Number | 880.5560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-21 |
Decision Date | 1987-10-13 |