The following data is part of a premarket notification filed by Arthro-medic, Inc. with the FDA for Hydraulic Foot Operated Stool.
Device ID | K893598 |
510k Number | K893598 |
Device Name: | HYDRAULIC FOOT OPERATED STOOL |
Classification | Chair, Surgical, Ac-powered |
Applicant | ARTHRO-MEDIC, INC. 4203 BELFORT RD., SUITE 150 Jacksonville, FL 32216 |
Contact | Webster Williams |
Correspondent | Webster Williams ARTHRO-MEDIC, INC. 4203 BELFORT RD., SUITE 150 Jacksonville, FL 32216 |
Product Code | GBB |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-09 |
Decision Date | 1989-10-10 |