The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed Arthroscopic Blades.
| Device ID | K012346 |
| 510k Number | K012346 |
| Device Name: | VANGUARD REPROCESSED ARTHROSCOPIC BLADES |
| Classification | Arthroscope |
| Applicant | VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Contact | Mike Sammon |
| Correspondent | Mike Sammon VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-24 |
| Decision Date | 2001-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825014651 | K012346 | 000 |
| 30885825012701 | K012346 | 000 |
| 30885825012718 | K012346 | 000 |
| 30885825012725 | K012346 | 000 |
| 30885825012732 | K012346 | 000 |
| 30885825012749 | K012346 | 000 |
| 30885825012756 | K012346 | 000 |
| 30885825012763 | K012346 | 000 |
| 30885825012770 | K012346 | 000 |
| 30885825012787 | K012346 | 000 |
| 30885825012794 | K012346 | 000 |
| 30885825012800 | K012346 | 000 |
| 30885825012817 | K012346 | 000 |
| 30885825012886 | K012346 | 000 |
| 30885825012930 | K012346 | 000 |
| 30885825013029 | K012346 | 000 |
| 30885825012695 | K012346 | 000 |