The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Detector, Bubble & Foam.
Device ID | K780582 |
510k Number | K780582 |
Device Name: | DETECTOR, BUBBLE & FOAM |
Classification | Detector, Air Bubble |
Applicant | HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FJF |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-12 |
Decision Date | 1978-06-22 |