The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Propper Vapor Line Pcd (steam Sterilization Process Challenge Test).
| Device ID | K031152 |
| 510k Number | K031152 |
| Device Name: | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City, NY 11101 |
| Contact | John D Dyckman |
| Correspondent | John D Dyckman 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-11 |
| Decision Date | 2004-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30818087010994 | K031152 | 000 |