The following data is part of a premarket notification filed by Medi-flex Hospital Products, Inc. with the FDA for Cepti-seal Dressing Change Kit For Venous Catheter.
Device ID | K921347 |
510k Number | K921347 |
Device Name: | CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER |
Classification | Wound Dressing Kit |
Applicant | MEDI-FLEX HOSPITAL PRODUCTS, INC. 8717 W. 110TH ST., SUITE 750 Overland Park, KS 66210 -2103 |
Contact | Orlando Cordova |
Correspondent | Orlando Cordova MEDI-FLEX HOSPITAL PRODUCTS, INC. 8717 W. 110TH ST., SUITE 750 Overland Park, KS 66210 -2103 |
Product Code | MCY |
CFR Regulation Number | 880.5075 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-18 |
Decision Date | 1993-01-08 |