The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Endoscopic Applicator.
| Device ID | K031882 |
| 510k Number | K031882 |
| Device Name: | ENDOSCOPIC APPLICATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | BAXTER HEALTHCARE CORP. 34175 ARDENWOOD BLVD. Fremont, CA 94555 |
| Contact | Lori Dondiego |
| Correspondent | Lori Dondiego BAXTER HEALTHCARE CORP. 34175 ARDENWOOD BLVD. Fremont, CA 94555 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-18 |
| Decision Date | 2003-09-05 |
| Summary: | summary |