The following data is part of a premarket notification filed by Steritec Products, Inc. with the FDA for Bowie-dick Mini Pak, Model Bd 115.
Device ID | K024293 |
510k Number | K024293 |
Device Name: | BOWIE-DICK MINI PAK, MODEL BD 115 |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | STERITEC PRODUCTS, INC. 599 TOPEKA WAY, SUITE 700 Castle Rock, CO 80109 |
Contact | Linda Nelson |
Correspondent | Linda Nelson STERITEC PRODUCTS, INC. 599 TOPEKA WAY, SUITE 700 Castle Rock, CO 80109 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-24 |
Decision Date | 2003-08-11 |