The following data is part of a premarket notification filed by Columbus Dental Mfg. Co. with the FDA for Ivory Premium Rubber Dam.
Device ID | K863816 |
510k Number | K863816 |
Device Name: | IVORY PREMIUM RUBBER DAM |
Classification | Dam, Rubber |
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 | EIE |
CFR Regulation Number | 872.6300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-30 |
Decision Date | 1986-10-27 |