The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Control Cover Gown.
Device ID | K840229 |
510k Number | K840229 |
Device Name: | CONTROL COVER GOWN |
Classification | Gown, Isolation, Surgical |
Applicant | KIMBERLY-CLARK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FYC |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-20 |
Decision Date | 1984-03-19 |