The following data is part of a premarket notification filed by Global Medical Prods, Inc. with the FDA for Merivaara Obstetric Chair/bed-model 358.
Device ID | K862931 |
510k Number | K862931 |
Device Name: | MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 |
Classification | Table, Obstetric (and Accessories) |
Applicant | GLOBAL MEDICAL PRODS, INC. 431 SOUTH DEARBORN ST. SUITE 705 Chicago, IL 60605 |
Contact | Glenn Z Hering |
Correspondent | Glenn Z Hering GLOBAL MEDICAL PRODS, INC. 431 SOUTH DEARBORN ST. SUITE 705 Chicago, IL 60605 |
Product Code | KNC |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-04 |
Decision Date | 1986-08-07 |