The following data is part of a premarket notification filed by Stanco Medical, Inc. with the FDA for Regional Intravenous Anesthesia Kit.
Device ID | K802290 |
510k Number | K802290 |
Device Name: | REGIONAL INTRAVENOUS ANESTHESIA KIT |
Classification | Anesthesia Conduction Kit |
Applicant | STANCO MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-19 |
Decision Date | 1980-10-17 |