The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact, Model 303.
Device ID | K820337 |
510k Number | K820337 |
Device Name: | IMPACT, MODEL 303 |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | IMPACT INSTRUMENTATION, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-08 |
Decision Date | 1982-03-02 |