The following data is part of a premarket notification filed by Vencor with the FDA for Nec-kradle By Vencor.
Device ID | K844239 |
510k Number | K844239 |
Device Name: | NEC-KRADLE BY VENCOR |
Classification | Apparatus, Traction, Non-powered |
Applicant | VENCOR 50 CURTNER AVE., #9 Campbell, CA 95008 |
Contact | Joan K Graham |
Correspondent | Joan K Graham VENCOR 50 CURTNER AVE., #9 Campbell, CA 95008 |
Product Code | HST |
CFR Regulation Number | 888.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-01 |
Decision Date | 1984-11-19 |