The following data is part of a premarket notification filed by National Healthcare Mfg. Corp. with the FDA for Nhmc Foley Catheterization Tray.
| Device ID | K960566 |
| 510k Number | K960566 |
| Device Name: | NHMC FOLEY CATHETERIZATION TRAY |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | NATIONAL HEALTHCARE MFG. CORP. 251 SAULTEAUX CRESCENT Winnipeg, Manitoba, CA R3j 3c7 |
| Contact | Bob Jackson |
| Correspondent | Bob Jackson NATIONAL HEALTHCARE MFG. CORP. 251 SAULTEAUX CRESCENT Winnipeg, Manitoba, CA R3j 3c7 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-09 |
| Decision Date | 1996-02-29 |