The following data is part of a premarket notification filed by National Healthcare Mfg. Corp. with the FDA for Nhmc Urethral Catheterization Tray.
Device ID | K962254 |
510k Number | K962254 |
Device Name: | NHMC URETHRAL 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 | 1996-06-12 |
Decision Date | 1996-07-29 |