The following data is part of a premarket notification filed by Pennwalt Corp. with the FDA for S.s. White-pennwalt Renew Calcium Hydrox.
| Device ID | K801860 |
| 510k Number | K801860 |
| Device Name: | S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | PENNWALT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-05 |
| Decision Date | 1980-10-10 |