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 |