The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Kc100 Surgical Drapes, Model Kc 100, Kimberly-clark Kc100 Surgical Equipment Covers, Model Kc 100.
Device ID | K083234 |
510k Number | K083234 |
Device Name: | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 |
Classification | Drape, Surgical |
Applicant | KIMBERLY-CLARK CORP. 172 CONDUCTOR DRIVE Dawsonville, GA 30534 |
Contact | Lisa Peacock |
Correspondent | Lisa Peacock KIMBERLY-CLARK CORP. 172 CONDUCTOR DRIVE Dawsonville, GA 30534 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-03 |
Decision Date | 2009-03-25 |
Summary: | summary |