The following data is part of a premarket notification filed by Das Medical, Llc with the FDA for Das Medical Equipment Drapes.
Device ID | K121436 |
510k Number | K121436 |
Device Name: | DAS MEDICAL EQUIPMENT DRAPES |
Classification | Drape, Surgical |
Applicant | DAS MEDICAL, LLC 100 ROSECREST LANE Columbus, MS 39701 |
Contact | Armond Groves |
Correspondent | Armond Groves DAS MEDICAL, LLC 100 ROSECREST LANE Columbus, MS 39701 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-15 |
Decision Date | 2013-06-06 |
Summary: | summary |