The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimguard Procedure Tray.
| Device ID | K852203 |
| 510k Number | K852203 |
| Device Name: | KIMGUARD PROCEDURE TRAY |
| Classification | Wrap, Sterilization |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Der Wa |
| Correspondent | Der Wa 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 | 1985-05-21 |
| Decision Date | 1985-06-07 |