The following data is part of a premarket notification filed by Busse Hospital Disposables with the FDA for Busse Epidural Catheter Kit.
Device ID | K093920 |
510k Number | K093920 |
Device Name: | BUSSE EPIDURAL CATHETER KIT |
Classification | Catheter, Conduction, Anesthetic |
Applicant | BUSSE HOSPITAL DISPOSABLES 75 ARKAY DRIVE Hauppauge, NY 11788 |
Contact | Muhamad Ansari |
Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES 75 ARKAY DRIVE Hauppauge, NY 11788 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-22 |
Decision Date | 2010-08-06 |
Summary: | summary |