The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed Hand-activated Ultrasonic Scalpel.
| Device ID | K043315 |
| 510k Number | K043315 |
| Device Name: | VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL |
| Classification | Scalpel, Ultrasonic, 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 | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-01 |
| Decision Date | 2005-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825016327 | K043315 | 000 |
| 30885825016310 | K043315 | 000 |
| 30885825016303 | K043315 | 000 |
| 30885825014767 | K043315 | 000 |