The following data is part of a premarket notification filed by Pymah Corp., Ati Div. with the FDA for Ati Disp. Biological Test Pack For Ethylene Oxide.
| Device ID | K895704 |
| 510k Number | K895704 |
| Device Name: | ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | PYMAH CORP., ATI DIV. REGULATORY CONSULTANT 8904 PADDOCK LANE Potomac, MD 20854 |
| Contact | L Konopko |
| Correspondent | L Konopko PYMAH CORP., ATI DIV. REGULATORY CONSULTANT 8904 PADDOCK LANE Potomac, MD 20854 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-22 |
| Decision Date | 1990-03-08 |