The following data is part of a premarket notification filed by G & W Applied Science Laboratories with the FDA for 4600 Recorder.
Device ID | K780677 |
510k Number | K780677 |
Device Name: | 4600 RECORDER |
Classification | Recorder, Paper Chart |
Applicant | G & W APPLIED SCIENCE LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-24 |
Decision Date | 1978-05-17 |