The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Propper Eo Line Ethylene Oxide Sterilization Integrator.
| Device ID | K973585 |
| 510k Number | K973585 |
| Device Name: | PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City, NY 11101 |
| Contact | Frank E Platko |
| Correspondent | Frank E Platko 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 | 1997-09-22 |
| Decision Date | 1998-11-06 |