The following data is part of a premarket notification filed by Excel Medical Products, Inc. with the FDA for Model 1080 Roller Massage Table.
Device ID | K883357 |
510k Number | K883357 |
Device Name: | MODEL 1080 ROLLER MASSAGE TABLE |
Classification | Table, Physical Therapy, Multi Function |
Applicant | EXCEL MEDICAL PRODUCTS, INC. 2610-4 WEST MARSHALL DR. Grand Prairie, TX 75051 |
Contact | Scott T Jones |
Correspondent | Scott T Jones EXCEL MEDICAL PRODUCTS, INC. 2610-4 WEST MARSHALL DR. Grand Prairie, TX 75051 |
Product Code | JFB |
CFR Regulation Number | 890.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-09 |
Decision Date | 1988-08-23 |