The following data is part of a premarket notification filed by Deseret Medical, Inc. with the FDA for Deseret Splittable Catheter.
Device ID | K874582 |
510k Number | K874582 |
Device Name: | DESERET SPLITTABLE CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | E. F Cleary |
Correspondent | E. F Cleary DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-09 |
Decision Date | 1987-12-29 |