The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Styptin, Hemogin-l, Hemodettes, And Gingigel Aluminum Chloride Impregnated Retraction Cord/materials.
| Device ID | K162948 |
| 510k Number | K162948 |
| Device Name: | Styptin, Hemogin-L, Hemodettes, And GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials |
| Classification | Cord, Retraction |
| Applicant | KERR CORPORATION 1717 W. COLLINS AVE. Orange, CA 92867 |
| Contact | Jennifer Dzidrums |
| Correspondent | Mohammad Saad Ansari SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVE. Orange, CA 92867 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-21 |
| Decision Date | 2017-08-08 |
| Summary: | summary |