The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Modification To:specialty Needles.
| Device ID | K073222 |
| 510k Number | K073222 |
| Device Name: | MODIFICATION TO:SPECIALTY NEEDLES |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| 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 | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-15 |
| Decision Date | 2008-04-09 |
| Summary: | summary |