The following data is part of a premarket notification filed by Pymah Corp., Ati Div. with the FDA for Ati-pymah Disposable Steam Biological Test Pack.
| Device ID | K884615 |
| 510k Number | K884615 |
| Device Name: | ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | PYMAH CORP., ATI DIV. 11471 VANOWEN ST. North Hollywood, CA 91605 |
| Contact | Roberta Parmelee |
| Correspondent | Roberta Parmelee PYMAH CORP., ATI DIV. 11471 VANOWEN ST. North 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 | 1988-11-04 |
| Decision Date | 1989-01-19 |