The following data is part of a premarket notification filed by Waismed Ltd. with the FDA for Bone Injection Gun (b.i.g.) Device.
| Device ID | K981853 |
| 510k Number | K981853 |
| Device Name: | BONE INJECTION GUN (B.I.G.) DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WAISMED LTD. P.O.B. 454 Ginot Shomron, IL 44853 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein WAISMED LTD. P.O.B. 454 Ginot Shomron, IL 44853 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-26 |
| Decision Date | 1998-11-17 |