The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Sterigage Integrator Test Pack For Steam Sterili..
Device ID | K894399 |
510k Number | K894399 |
Device Name: | STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI. |
Classification | Indicator, Biological Sterilization Process |
Applicant | PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
Contact | Roberta Parmelee |
Correspondent | Roberta Parmelee 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 | 1989-07-17 |
Decision Date | 1989-09-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50707387469172 | K894399 | 000 |