The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Medical Diagnostic Videocassette.
Device ID | K931604 |
510k Number | K931604 |
Device Name: | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE |
Classification | Film, Radiographic |
Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
Contact | Anna Mcright |
Correspondent | Anna Mcright 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
Product Code | IWZ |
CFR Regulation Number | 892.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-01 |
Decision Date | 1993-07-21 |