The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Amsco Orthographic 2 Table.
Device ID | K823772 |
510k Number | K823772 |
Device Name: | AMSCO ORTHOGRAPHIC 2 TABLE |
Classification | Table And Attachments, Operating-room |
Applicant | AMERICAN STERILIZER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BWN |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-14 |
Decision Date | 1983-01-14 |