The following data is part of a premarket notification filed by Clinical Neuro Systems Llc. with the FDA for Cns Interchangeable Bit Cranial Drill.
| Device ID | K961113 |
| 510k Number | K961113 |
| Device Name: | CNS INTERCHANGEABLE BIT CRANIAL DRILL |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | CLINICAL NEURO SYSTEMS LLC. 309 COMMERCE DR. Exton, PA 19341 |
| Contact | Jim Meikle |
| Correspondent | Jim Meikle CLINICAL NEURO SYSTEMS LLC. 309 COMMERCE DR. Exton, PA 19341 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-20 |
| Decision Date | 1996-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780537342 | K961113 | 000 |
| 10381780537335 | K961113 | 000 |
| 10381780537328 | K961113 | 000 |
| 10381780263890 | K961113 | 000 |
| 10381780537304 | K961113 | 000 |