The following data is part of a premarket notification filed by Columbus Dental Mfg. Co. with the FDA for Shur Gel 4.
| Device ID | K860855 |
| 510k Number | K860855 |
| Device Name: | SHUR GEL 4 |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-07 |
| Decision Date | 1986-06-16 |