The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed Arthroscopic Wands.
| Device ID | K043198 |
| 510k Number | K043198 |
| Device Name: | VANGUARD REPROCESSED ARTHROSCOPIC WANDS |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, 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 | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-18 |
| Decision Date | 2005-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825014514 | K043198 | 000 |
| 30885825014316 | K043198 | 000 |
| 30885825014217 | K043198 | 000 |
| 30885825014101 | K043198 | 000 |
| 30885825013326 | K043198 | 000 |