The following data is part of a premarket notification filed by Mcb Manufacturing Chemists, Inc. with the FDA for Entellan.
| Device ID | K800847 |
| 510k Number | K800847 |
| Device Name: | ENTELLAN |
| Classification | Media, Mounting, Oil Soluble |
| Applicant | MCB MANUFACTURING CHEMISTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KEP |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-15 |
| Decision Date | 1980-05-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENTELLAN 72424800 0958836 Dead/Expired |
E. MERCK 1972-05-18 |