The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Cradle, Hospital Bed Clothing.
Device ID | K892877 |
510k Number | K892877 |
Device Name: | CRADLE, HOSPITAL BED CLOTHING |
Classification | Bed, Manual |
Applicant | WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
Contact | James Ritter |
Correspondent | James Ritter WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
Product Code | FNJ |
CFR Regulation Number | 880.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-19 |
Decision Date | 1989-06-15 |