The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Busse Hospital Disposables Needle Stick Block/cube.
| Device ID | K052843 |
| 510k Number | K052843 |
| Device Name: | BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DRIVE P.O. BOX 11067 Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DRIVE P.O. BOX 11067 Hauppauge, NY 11788 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-07 |
| Decision Date | 2006-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10849233011769 | K052843 | 000 |