The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed Dilating Tip And Blunt Trocars.
| Device ID | K043253 |
| 510k Number | K043253 |
| Device Name: | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Contact | Heather Crawford |
| Correspondent | Heather Crawford VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-24 |
| Decision Date | 2005-04-08 |
| Summary: | summary |