The following data is part of a premarket notification filed by Laboratoires Luneau with the FDA for Luneau Umbilical Cord Clamp.
Device ID | K923439 |
510k Number | K923439 |
Device Name: | LUNEAU UMBILICAL CORD CLAMP |
Classification | Clamp, Umbilical |
Applicant | LABORATOIRES LUNEAU B.P 252 28005 CHARTRES CEDEX France, FR |
Contact | Young |
Correspondent | Young LABORATOIRES LUNEAU B.P 252 28005 CHARTRES CEDEX France, FR |
Product Code | HFW |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-13 |
Decision Date | 1993-05-21 |