The following data is part of a premarket notification filed by Klein-baker Medical, Inc. with the FDA for Neo-care Catheterization Tray.
| Device ID | K963867 |
| 510k Number | K963867 |
| Device Name: | NEO-CARE CATHETERIZATION TRAY |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | KLEIN-BAKER MEDICAL, INC. 12001 NETWORK, SUITE 110 San Antonio, TX 78249 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker KLEIN-BAKER MEDICAL, INC. 12001 NETWORK, SUITE 110 San Antonio, TX 78249 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-26 |
| Decision Date | 1996-11-06 |