The following data is part of a premarket notification filed by Busse Hosipital Disposables with the FDA for Busse Surgical Drape.
| Device ID | K083424 |
| 510k Number | K083424 |
| Device Name: | BUSSE SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | BUSSE HOSIPITAL DISPOSABLES 75 ARKAY DR Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSIPITAL DISPOSABLES 75 ARKAY DR Hauppauge, NY 11788 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-19 |
| Decision Date | 2009-02-26 |
| Summary: | summary |