The following data is part of a premarket notification filed by Deseret Medical, Inc. with the FDA for Deseret Prn Adapter.
Device ID | K893406 |
510k Number | K893406 |
Device Name: | DESERET PRN ADAPTER |
Classification | Accessories, Catheter |
Applicant | DESERET MEDICAL, INC. 9450 SOUTH STATE ST. SANDY, UT 84070 |
Contact | CHARLES J WELLE |
Correspondent | CHARLES J WELLE DESERET MEDICAL, INC. 9450 SOUTH STATE ST. SANDY, UT 84070 |
Product Code | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-02 |
Decision Date | 1989-06-22 |