The following data is part of a premarket notification filed by Colgate-palmolive Co. with the FDA for Colgate Precision Mint Wzxed Dental Floss.
Device ID | K944886 |
510k Number | K944886 |
Device Name: | COLGATE PRECISION MINT WZXED DENTAL FLOSS |
Classification | Floss, Dental |
Applicant | COLGATE-PALMOLIVE CO. P.O. BOX 1343 909 RIVER ROAD Piscataway, NJ 08855 -1343 |
Contact | Paul J Okarma |
Correspondent | Paul J Okarma COLGATE-PALMOLIVE CO. P.O. BOX 1343 909 RIVER ROAD Piscataway, NJ 08855 -1343 |
Product Code | JES |
CFR Regulation Number | 872.6390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-03 |
Decision Date | 1995-04-27 |