The following data is part of a premarket notification filed by S & W Enterprises, Inc. with the FDA for S & W Model Aso.
Device ID | K830873 |
510k Number | K830873 |
Device Name: | S & W MODEL ASO |
Classification | Table, Obstetric (and Accessories) |
Applicant | S & W ENTERPRISES, INC. 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 | 1983-03-18 |
Decision Date | 1983-05-13 |