The following data is part of a premarket notification filed by Cox Sterile Products, Inc. with the FDA for Steriking, See & Peel.
Device ID | K922440 |
510k Number | K922440 |
Device Name: | STERIKING, SEE & PEEL |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | COX STERILE PRODUCTS, INC. 5115 MCKINNEY AVENUE, SUITE C Dallas, TX 75205 |
Contact | Mark J Gainor |
Correspondent | Mark J Gainor COX STERILE PRODUCTS, INC. 5115 MCKINNEY AVENUE, SUITE C Dallas, TX 75205 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-22 |
Decision Date | 1994-09-26 |