The following data is part of a premarket notification filed by Cox Sterile Products, Inc. with the FDA for Cox Rapid Heat Transfer Sterilizer.
Device ID | K872643 |
510k Number | K872643 |
Device Name: | COX RAPID HEAT TRANSFER STERILIZER |
Classification | Sterilizer, Dry Heat |
Applicant | COX STERILE PRODUCTS, INC. 5115 MCKINNEY AVENUE, SUITE C Dallas, TX 75205 |
Contact | Cox, Dds |
Correspondent | Cox, Dds COX STERILE PRODUCTS, INC. 5115 MCKINNEY AVENUE, SUITE C Dallas, TX 75205 |
Product Code | KMH |
CFR Regulation Number | 880.6870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-06 |
Decision Date | 1987-10-29 |