The following data is part of a premarket notification filed by U.s. Table, Inc. with the FDA for Ash-7000.
Device ID | K951228 |
510k Number | K951228 |
Device Name: | ASH-7000 |
Classification | Equipment, Traction, Powered |
Applicant | U.S. TABLE, INC. 11233 WASHINGTON HIGHWAY Glen Allen, VA 23059 |
Contact | Brenda Cassell |
Correspondent | Brenda Cassell U.S. TABLE, INC. 11233 WASHINGTON HIGHWAY Glen Allen, VA 23059 |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-20 |
Decision Date | 1995-05-17 |