The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Busse Umbilical Cord Clamp Cutter.
| Device ID | K021055 |
| 510k Number | K021055 |
| Device Name: | BUSSE UMBILICAL CORD CLAMP CUTTER |
| Classification | Clamp, Umbilical |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 2156 Huntington, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 2156 Huntington, CT 06484 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-01 |
| Decision Date | 2002-04-29 |
| Summary: | summary |