The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Rigident Cream.
| Device ID | K854430 |
| 510k Number | K854430 |
| Device Name: | RIGIDENT CREAM |
| Classification | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Stephen Kolakosky |
| Correspondent | Stephen Kolakosky ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | KOT |
| CFR Regulation Number | 872.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-05 |
| Decision Date | 1986-03-04 |