The following data is part of a premarket notification filed by Micromar Ind. Com. Ltd. with the FDA for Easydrill Autostop Cranial Perforator.
| Device ID | K141455 |
| 510k Number | K141455 |
| Device Name: | EASYDRILL AUTOSTOP CRANIAL PERFORATOR |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Applicant | MICROMAR IND. COM. LTD. 4620 NORTH BEACH STREET Fort Worth, TX 76137 |
| Contact | Deep Pal |
| Correspondent | Deep Pal MICROMAR IND. COM. LTD. 4620 NORTH BEACH STREET Fort Worth, TX 76137 |
| Product Code | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2015-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07898959543197 | K141455 | 000 |
| 07898959543609 | K141455 | 000 |
| 07898959543616 | K141455 | 000 |
| 07898959543623 | K141455 | 000 |
| 07898959543555 | K141455 | 000 |
| 07898959543562 | K141455 | 000 |
| 07898959543579 | K141455 | 000 |
| 07898959543586 | K141455 | 000 |
| 07898959543470 | K141455 | 000 |
| 07898959543487 | K141455 | 000 |
| 07898959543494 | K141455 | 000 |
| 07898959543500 | K141455 | 000 |
| 07898959543166 | K141455 | 000 |
| 07898959543173 | K141455 | 000 |
| 07898959543180 | K141455 | 000 |
| 07898959543593 | K141455 | 000 |