The following data is part of a premarket notification filed by Minrad, Inc. with the FDA for Sabresource Drape.
Device ID | K041846 |
510k Number | K041846 |
Device Name: | SABRESOURCE DRAPE |
Classification | Drape, Surgical |
Applicant | MINRAD, INC. 847 MAIN ST. Buffalo, NY 14203 |
Contact | John Mcneirney |
Correspondent | John Mcneirney MINRAD, INC. 847 MAIN ST. Buffalo, NY 14203 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-07-08 |
Decision Date | 2004-08-26 |
Summary: | summary |