The following data is part of a premarket notification filed by Salt Creek Medical Technologies with the FDA for Scmt Umbilical Clamp.
Device ID | K871075 |
510k Number | K871075 |
Device Name: | SCMT UMBILICAL CLAMP |
Classification | Clamp, Umbilical |
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 | HFW |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-18 |
Decision Date | 1987-03-23 |