The following data is part of a premarket notification filed by Propper Manufacturing Co., Inc. with the FDA for Gas-chex Indicator.
| Device ID | K212592 |
| 510k Number | K212592 |
| Device Name: | Gas-Chex Indicator |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | Propper Manufacturing Co., Inc. 36-04 Skillman Avenue Long Island City, NY 11101 |
| Contact | Andrew Sharavara |
| Correspondent | Andrew Sharavara Propper Manufacturing Co., Inc. 36-04 Skillman Avenue Long Island City, NY 11101 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2022-01-20 |