The following data is part of a premarket notification filed by Medi-flex Hospital Products, Inc. with the FDA for Port-a-cath Access Kit.
| Device ID | K952201 |
| 510k Number | K952201 |
| Device Name: | PORT-A-CATH ACCESS KIT |
| Classification | Syringe, Piston |
| 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 | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-10 |
| Decision Date | 1995-10-04 |