The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Brain Biopsy Needle.
| Device ID | K112094 |
| 510k Number | K112094 |
| Device Name: | BRAIN BIOPSY NEEDLE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | AD-TECH MEDICAL INSTRUMENT CORP. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary J Syring |
| Correspondent | Gary J Syring AD-TECH MEDICAL INSTRUMENT CORP. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2012-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841823106674 | K112094 | 000 |