The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Comprinet, Comtesse And Bellavar Stockings.
Device ID | K905631 |
510k Number | K905631 |
Device Name: | COMPRINET, COMTESSE AND BELLAVAR STOCKINGS |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | JOBST INSTITUTE, INC. BOX 653 Toledo, OH 43694 |
Contact | Bruce Wetzel |
Correspondent | Bruce Wetzel JOBST INSTITUTE, INC. BOX 653 Toledo, OH 43694 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-17 |
Decision Date | 1991-03-07 |