The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Cross-checks P.
Device ID | K972300 |
510k Number | K972300 |
Device Name: | CROSS-CHECKS P |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY SUITE 600 Castle Rock, CO 80104 |
Contact | Tom Roll |
Correspondent | Tom Roll STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY SUITE 600 Castle Rock, CO 80104 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-19 |
Decision Date | 1998-03-25 |
Summary: | summary |