The following data is part of a premarket notification filed by Techstyles with the FDA for Duratech Hospital Towel.
Device ID | K920045 |
510k Number | K920045 |
Device Name: | DURATECH HOSPITAL TOWEL |
Classification | Drape, Surgical |
Applicant | TECHSTYLES 6600 LBJ FREEWAY #4145 Dallas, TX 75240 |
Contact | Winfield Singletary |
Correspondent | Winfield Singletary TECHSTYLES 6600 LBJ FREEWAY #4145 Dallas, TX 75240 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-06 |
Decision Date | 1992-07-02 |