The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Abco Examination Lamp (gooseneck Type).
Device ID | K800230 |
510k Number | K800230 |
Device Name: | ABCO EXAMINATION LAMP (GOOSENECK TYPE) |
Classification | Device, Medical Examination, Ac Powered |
Applicant | ABCO DEALERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KZF |
CFR Regulation Number | 880.6320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-05 |
Decision Date | 1980-02-26 |