The following data is part of a premarket notification filed by Waismed Ltd. with the FDA for Bone Injection Gun (b.i.g.) For Pediatrics, Model 1st.
| Device ID | K022415 |
| 510k Number | K022415 |
| Device Name: | BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WAISMED LTD. 117 AHUZAH ST Ra'ananna, IL |
| Contact | Dorit Winitz |
| Correspondent | Dorit Winitz WAISMED LTD. 117 AHUZAH ST Ra'ananna, IL |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-24 |
| Decision Date | 2002-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290008325049 | K022415 | 000 |