The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Ati Disposable Test Pack For Steam Sterilization.
| Device ID | K952408 |
| 510k Number | K952408 |
| Device Name: | ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PYMAH CORP. 8904 PADDOCK LN. Potomac, MD 20854 |
| Contact | Bernard Konopko |
| Correspondent | Bernard Konopko PYMAH CORP. 8904 PADDOCK LN. Potomac, MD 20854 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-22 |
| Decision Date | 1995-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387236477 | K952408 | 000 |
| 50707387236453 | K952408 | 000 |