The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Suction Coagulator.
Device ID | K800321 |
510k Number | K800321 |
Device Name: | CONCEPT SUCTION COAGULATOR |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-12 |
Decision Date | 1980-02-28 |