The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Sterigage Eo 100%.
Device ID | K934874 |
510k Number | K934874 |
Device Name: | STERIGAGE EO 100% |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
Contact | Bernard Konopko, R.ph., P.d. |
Correspondent | Bernard Konopko, R.ph., P.d. PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-12 |
Decision Date | 1995-04-18 |