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 |