The following data is part of a premarket notification filed by Medical Sales Co. with the FDA for Umbilical Cord Clamp.
Device ID | K994367 |
510k Number | K994367 |
Device Name: | UMBILICAL CORD CLAMP |
Classification | Clamp, Umbilical |
Applicant | MEDICAL SALES CO. P.O. BOX 540314 101 N. 700 WEST North Salt Lake, UT 84054 |
Contact | John E Lincoln |
Correspondent | John E Lincoln MEDICAL SALES CO. P.O. BOX 540314 101 N. 700 WEST North Salt Lake, UT 84054 |
Product Code | HFW |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-27 |
Decision Date | 2000-03-17 |
Summary: | summary |