The following data is part of a premarket notification filed by Jobst A Beiersdorf Co. with the FDA for Jobst Athrombic Pump System 2100.
Device ID | K963929 |
510k Number | K963929 |
Device Name: | JOBST ATHROMBIC PUMP SYSTEM 2100 |
Classification | Sleeve, Limb, Compressible |
Applicant | JOBST A BEIERSDORF CO. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
Contact | Angelo R Pereira |
Correspondent | Angelo R Pereira JOBST A BEIERSDORF CO. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-05 |
Decision Date | 1997-01-27 |
Summary: | summary |