The following data is part of a premarket notification filed by Northern Medical Industries with the FDA for Suction Catheter.
Device ID | K813163 |
510k Number | K813163 |
Device Name: | SUCTION CATHETER |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | NORTHERN MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-10 |
Decision Date | 1981-12-29 |