The following data is part of a premarket notification filed by Confection Medicale D.r., Inc. with the FDA for D. R. Medical Controlled Pressure Garments.
Device ID | K001300 |
510k Number | K001300 |
Device Name: | D. R. MEDICAL CONTROLLED PRESSURE GARMENTS |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | CONFECTION MEDICALE D.R., INC. 4220, DE ROUEN ST. #200 Montreal, Qc, CA Hiv 3t2 |
Contact | Guy Houde |
Correspondent | Guy Houde CONFECTION MEDICALE D.R., INC. 4220, DE ROUEN ST. #200 Montreal, Qc, CA Hiv 3t2 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-24 |
Decision Date | 2000-08-30 |