The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Ati(r) Disp Biological-plus Test Pack.
| Device ID | K925745 |
| 510k Number | K925745 |
| Device Name: | ATI(R) DISP BIOLOGICAL-PLUS TEST PACK |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
| Contact | Raymond P Larsson |
| Correspondent | Raymond P Larsson PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-13 |
| Decision Date | 1994-02-01 |