The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Self-seal Pouch For Low Temperature Sterilization.
| Device ID | K973827 |
| 510k Number | K973827 |
| Device Name: | KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Larry K Ludt |
| Correspondent | Larry K Ludt KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1998-02-11 |
| Summary: | summary |