The following data is part of a premarket notification filed by Columbus Dental Mfg. Co. with the FDA for Utility Wax Strips, Cinnamon.
Device ID | K880606 |
510k Number | K880606 |
Device Name: | UTILITY WAX STRIPS, CINNAMON |
Classification | Wax, Dental, Intraoral |
Applicant | COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis, MO 63188 |
Contact | John S Frierdich |
Correspondent | John S Frierdich COLUMBUS DENTAL MFG. CO. 1000 CHOUTEAU AVE. P.O. BOX 620 St. Louis, MO 63188 |
Product Code | EGD |
CFR Regulation Number | 872.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-12 |
Decision Date | 1988-03-24 |