The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Sterilization Process Indicator.
| Device ID | K841168 |
| 510k Number | K841168 |
| Device Name: | STERILIZATION PROCESS INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PARKE-DAVIS CO. 2337 PARKDALE AVE. Brookville, Ontario, CA K62 5ws |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-19 |
| Decision Date | 1984-05-09 |