The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Ad-tech's Brain Biopsy Needle For Stereotaxic.
| Device ID | K924348 |
| 510k Number | K924348 |
| Device Name: | AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Contact | Anthony Putz |
| Correspondent | Anthony Putz AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-27 |
| Decision Date | 1992-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841823100979 | K924348 | 000 |
| 00841823100887 | K924348 | 000 |
| 00841823100894 | K924348 | 000 |
| 00841823100900 | K924348 | 000 |
| 00841823100917 | K924348 | 000 |
| 00841823100924 | K924348 | 000 |
| 00841823100931 | K924348 | 000 |
| 00841823100948 | K924348 | 000 |
| 00841823100955 | K924348 | 000 |
| 00841823100962 | K924348 | 000 |
| 00841823100870 | K924348 | 000 |