The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Busse Surgical Drapes Iii.
| Device ID | K092212 |
| 510k Number | K092212 |
| Device Name: | BUSSE SURGICAL DRAPES III |
| Classification | Drape, Surgical |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-22 |
| Decision Date | 2009-10-09 |
| Summary: | summary |