The following data is part of a premarket notification filed by Waismed Ltd. with the FDA for Bone Injection Gun (b.i.g.).
| Device ID | K062940 |
| 510k Number | K062940 |
| Device Name: | BONE INJECTION GUN (B.I.G.) |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WAISMED LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan WAISMED LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2006-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290008325032 | K062940 | 000 |