The following data is part of a premarket notification filed by Mego Afek Ac Ltd with the FDA for Pcd 737a.
Device ID | K140642 |
510k Number | K140642 |
Device Name: | PCD 737A |
Classification | Sleeve, Limb, Compressible |
Applicant | MEGO AFEK AC LTD KIBBUTZ AFEK Afek, IL 30042 |
Contact | Aharon Cohen |
Correspondent | Aharon Cohen MEGO AFEK AC LTD KIBBUTZ AFEK Afek, IL 30042 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-12 |
Decision Date | 2014-06-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290105879431 | K140642 | 000 |