The following data is part of a premarket notification filed by Kem Medical Products Corp. with the FDA for Lead-free Chemical Indicators For Steam Sterilization.
| Device ID | K181788 |
| 510k Number | K181788 |
| Device Name: | Lead-free Chemical Indicators For Steam Sterilization |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | Kem Medical Products Corp. 400 Broadhollow Road, Suite 2 Farmingdale, NY 11735 |
| Contact | Douglas A. Kruger |
| Correspondent | Douglas A. Kruger Kem Medical Products Corp. 400 Broadhollow Road, Suite 2 Farmingdale, NY 11735 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-05 |
| Decision Date | 2019-03-01 |
| Summary: | summary |