The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Introducer Kits.
Device ID | K080253 |
510k Number | K080253 |
Device Name: | KIMBERLY-CLARK INTRODUCER KITS |
Classification | Tube, Gastro-enterostomy |
Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
Contact | Sherry Saurini |
Correspondent | Sherry Saurini KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
Product Code | KGC |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-01-31 |
Decision Date | 2008-02-26 |
Summary: | summary |