The following data is part of a premarket notification filed by Beiersdorf-jobt, Inc. with the FDA for Jobst Ready-to-wear Arm Sleeves.
Device ID | K991570 |
510k Number | K991570 |
Device Name: | JOBST READY-TO-WEAR ARM SLEEVES |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | BEIERSDORF-JOBT, INC. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
Contact | Angelo R Pereira |
Correspondent | Angelo R Pereira BEIERSDORF-JOBT, INC. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-05 |
Decision Date | 1999-08-20 |
Summary: | summary |