The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Surgical Drapes With Aami Liquid Barrier Level 4 Claim.
| Device ID | K102666 |
| 510k Number | K102666 |
| Device Name: | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM |
| Classification | Drape, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. BLDG 300, #1093 Roswell, GA 30076 -2199 |
| Contact | Marcia Johnson |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-09-15 |
| Decision Date | 2010-11-09 |
| Summary: | summary |