The following data is part of a premarket notification filed by Baurs Krey Assoc., Inc. with the FDA for Glattelast Compression Panty Hose.
Device ID | K841252 |
510k Number | K841252 |
Device Name: | GLATTELAST COMPRESSION PANTY HOSE |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | BAURS KREY ASSOC., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-26 |
Decision Date | 1984-06-27 |