The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Gas Plasma Sterilization Indicator Strip.
| Device ID | K974415 |
| 510k Number | K974415 |
| Device Name: | KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Larry R Kludt |
| Correspondent | Larry R Kludt KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-24 |
| Decision Date | 1998-07-10 |
| Summary: | summary |