The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Electro-suction Unit.
Device ID | K810892 |
510k Number | K810892 |
Device Name: | ELECTRO-SUCTION UNIT |
Classification | Bottle, Collection, Vacuum |
Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-02 |
Decision Date | 1981-04-17 |