The following data is part of a premarket notification filed by Columbus Dental Mfg. Co. with the FDA for Dri-clave Liquid Kleenzall.
Device ID | K880754 |
510k Number | K880754 |
Device Name: | DRI-CLAVE LIQUID KLEENZALL |
Classification | Evacuator, Oral Cavity |
Applicant | COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis, MO 63188 |
Contact | Cheryl V Zimmerman |
Correspondent | Cheryl V Zimmerman COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis, MO 63188 |
Product Code | EHZ |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-25 |
Decision Date | 1988-05-12 |