The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Trilaminate Drapes/tiburon.
| Device ID | K023419 |
| 510k Number | K023419 |
| Device Name: | TRILAMINATE DRAPES/TIBURON |
| Classification | Drape, Surgical |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-11 |
| Decision Date | 2003-02-11 |
| Summary: | summary |