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 Cent Ven Cath.
| Device ID | K914316 |
| 510k Number | K914316 |
| Device Name: | CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH |
| Classification | Latex Patient Examination Glove |
| 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-26 |
| Decision Date | 1991-12-24 |