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 |