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 |