The following data is part of a premarket notification filed by Flexbar Machine Corp. with the FDA for Curved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical Handle.
| Device ID | K103840 |
| 510k Number | K103840 |
| Device Name: | CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | FLEXBAR MACHINE CORP. 30 NORTHPORT ROAD Sound Beach, NY 11764 |
| Contact | Stephen T Mlcoch |
| Correspondent | Stephen T Mlcoch FLEXBAR MACHINE CORP. 30 NORTHPORT ROAD Sound Beach, NY 11764 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-10 |
| Decision Date | 2011-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842102105937 | K103840 | 000 |
| 00842102104695 | K103840 | 000 |
| 00842102104671 | K103840 | 000 |
| 00842102104657 | K103840 | 000 |
| 00842102104633 | K103840 | 000 |
| 00842102104619 | K103840 | 000 |
| 00842102104596 | K103840 | 000 |
| 00842102104565 | K103840 | 000 |
| 00842102104541 | K103840 | 000 |
| 00842102104534 | K103840 | 000 |
| 00842102104527 | K103840 | 000 |
| 00842102104510 | K103840 | 000 |
| 00842102104503 | K103840 | 000 |
| 00842102104497 | K103840 | 000 |
| 00842102104480 | K103840 | 000 |
| 00842102104473 | K103840 | 000 |
| 00842102104466 | K103840 | 000 |
| 00842102104459 | K103840 | 000 |
| 00842102104701 | K103840 | 000 |
| 00842102104718 | K103840 | 000 |
| 00842102105050 | K103840 | 000 |
| 00842102105036 | K103840 | 000 |
| 00842102105005 | K103840 | 000 |
| 00842102104992 | K103840 | 000 |
| 00842102104985 | K103840 | 000 |
| 00842102104978 | K103840 | 000 |
| 00842102104961 | K103840 | 000 |
| 00842102104954 | K103840 | 000 |
| 00842102104947 | K103840 | 000 |
| 00842102104930 | K103840 | 000 |
| 00842102104923 | K103840 | 000 |
| 00842102104916 | K103840 | 000 |
| 00842102104909 | K103840 | 000 |
| 00842102104893 | K103840 | 000 |
| 00842102104749 | K103840 | 000 |
| 00842102104732 | K103840 | 000 |
| 00842102104725 | K103840 | 000 |
| 00842102104442 | K103840 | 000 |