The following data is part of a premarket notification filed by Amsco Co. with the FDA for Delivery 4 Table.
Device ID | K831309 |
510k Number | K831309 |
Device Name: | DELIVERY 4 TABLE |
Classification | Table, Obstetric (and Accessories) |
Applicant | AMSCO CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNC |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-22 |
Decision Date | 1983-06-15 |