The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Sterigage Integrator Test Pack For Ethylene Oxide.
| Device ID | K894398 |
| 510k Number | K894398 |
| Device Name: | STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | PYMAH CORP. ATI-DIVISION OF PYMAH CORP. 11471 VANOWEN STREET No. Hollywood, CA 91605 |
| Contact | Roberta Parmelee |
| Correspondent | Roberta Parmelee PYMAH CORP. ATI-DIVISION OF PYMAH CORP. 11471 VANOWEN STREET No. Hollywood, CA 91605 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-09-11 |