The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Guardian Sterilization Wrap.
| Device ID | K803294 |
| 510k Number | K803294 |
| Device Name: | GUARDIAN STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | KIMBERLY-CLARK CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-02-02 |