The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Steam Dot Blu Process Indicator.
| Device ID | K111453 |
| 510k Number | K111453 |
| Device Name: | STEAM DOT BLU PROCESS INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City, NY 11101 |
| Contact | Andrew Sharavara |
| Correspondent | Andrew Sharavara PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. 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 | 2011-05-25 |
| Decision Date | 2012-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30818087012967 | K111453 | 000 |