The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed Bladed Trocar, Non-bladed Trocar, Trocar Accessories.
| Device ID | K043594 |
| 510k Number | K043594 |
| Device Name: | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES |
| 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 | 2004-12-29 |
| Decision Date | 2005-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825016877 | K043594 | 000 |
| 30885825013777 | K043594 | 000 |
| 30885825013791 | K043594 | 000 |
| 30885825013807 | K043594 | 000 |
| 30885825013999 | K043594 | 000 |
| 30885825014040 | K043594 | 000 |
| 30885825015764 | K043594 | 000 |
| 30885825015771 | K043594 | 000 |
| 30885825016693 | K043594 | 000 |
| 30885825016853 | K043594 | 000 |
| 30885825016860 | K043594 | 000 |
| 30885825013760 | K043594 | 000 |