The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Ati Disposable Test Pack For Eo Gas Sterilization.
| Device ID | K951063 |
| 510k Number | K951063 |
| Device Name: | ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PYMAH CORP. 500 ROUTE 202 NORTH Flemington, NJ 08822 -6026 |
| Contact | George Levendusky |
| Correspondent | George Levendusky PYMAH CORP. 500 ROUTE 202 NORTH Flemington, NJ 08822 -6026 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-08 |
| Decision Date | 1995-05-10 |