The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Dukal Surgical Drape; Fenestrated Dukal Surgical Drape.
| Device ID | K083320 |
| 510k Number | K083320 |
| Device Name: | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | DUKAL CORP. 5 PLANT AVE Hauppauge, NY 11788 |
| Contact | Jim Vilardi |
| Correspondent | Jim Vilardi DUKAL CORP. 5 PLANT AVE 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 | 2008-11-12 |
| Decision Date | 2009-03-06 |
| Summary: | summary |