The following data is part of a premarket notification filed by John O. Butler Co. with the FDA for Vutler G.u.m. With Fluoride.
| Device ID | K952091 |
| 510k Number | K952091 |
| Device Name: | VUTLER G.U.M. WITH FLUORIDE |
| Classification | Floss, Dental |
| Applicant | JOHN O. BUTLER CO. 4635 W. FOSTER AVE. Chicago, IL 60630 |
| Contact | Christy Calhoon |
| Correspondent | Christy Calhoon JOHN O. BUTLER CO. 4635 W. FOSTER AVE. Chicago, IL 60630 |
| Product Code | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-03 |
| Decision Date | 1995-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20070942783358 | K952091 | 000 |