The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimguard (regular & Heavy Duty) Sterile Wrap.
| Device ID | K881471 |
| 510k Number | K881471 |
| Device Name: | KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP |
| Classification | Wrap, Sterilization |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Cynthia E Smith |
| Correspondent | Cynthia E Smith KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-07 |
| Decision Date | 1988-08-10 |