The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Drape Surgical Utility Drape Sterile.
| Device ID | K843496 |
| 510k Number | K843496 |
| Device Name: | DRAPE SURGICAL UTILITY DRAPE STERILE |
| Classification | Drape, Surgical |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik BUSSE HOSPITAL DISPOSABLES, INC. 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 | 1984-09-06 |
| Decision Date | 1984-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849233015043 | K843496 | 000 |
| 00849233013469 | K843496 | 000 |
| 00849233008410 | K843496 | 000 |