The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Anti-em/gp Stockings.
Device ID | K955138 |
510k Number | K955138 |
Device Name: | ANTI-EM/GP STOCKINGS |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | JOBST INSTITUTE, INC. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
Contact | Angelo R Pereira |
Correspondent | Angelo R Pereira JOBST INSTITUTE, 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 | 1995-11-13 |
Decision Date | 1995-12-13 |