The following data is part of a premarket notification filed by Veratex Corp. with the FDA for Sterile Drape 17x18 Code D-6a.
Device ID | K801032 |
510k Number | K801032 |
Device Name: | STERILE DRAPE 17X18 CODE D-6A |
Classification | Drape, Surgical |
Applicant | VERATEX CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-01 |
Decision Date | 1980-05-20 |