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 |