The following data is part of a premarket notification filed by Medi-flex Hospital Products, Inc. with the FDA for Picc Line Kit.
| Device ID | K952256 |
| 510k Number | K952256 |
| Device Name: | PICC LINE KIT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MEDI-FLEX HOSPITAL PRODUCTS, INC. 19 BUTTERFIELD TRAIL El Paso, TX 79906 |
| Contact | Orlando Cordova |
| Correspondent | Orlando Cordova MEDI-FLEX HOSPITAL PRODUCTS, INC. 19 BUTTERFIELD TRAIL El Paso, TX 79906 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-15 |
| Decision Date | 1995-07-31 |