The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Ok Flash Sterilization Indicator.
| Device ID | K834353 |
| 510k Number | K834353 |
| Device Name: | OK FLASH STERILIZATION INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PROPPER MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-13 |
| Decision Date | 1984-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30818087012288 | K834353 | 000 |