The following data is part of a premarket notification filed by Salt Creek Medical Technologies with the FDA for Urine Meter, 250cc.
Device ID | K871042 |
510k Number | K871042 |
Device Name: | URINE METER, 250CC |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | SALT CREEK MEDICAL TECHNOLOGIES 5500 ARAPAHO PASS Pinckney, MI 48169 |
Contact | Howard Meade |
Correspondent | Howard Meade SALT CREEK MEDICAL TECHNOLOGIES 5500 ARAPAHO PASS Pinckney, MI 48169 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-17 |
Decision Date | 1987-03-25 |