The following data is part of a premarket notification filed by Acra Cut, Inc. with the FDA for Acra-cut.
| Device ID | K833266 |
| 510k Number | K833266 |
| Device Name: | ACRA-CUT |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Applicant | ACRA CUT, INC. 979 MAIN STREET Acton , MA 01720 - |
| Contact | David L Mullin |
| Correspondent | David L Mullin ACRA CUT, INC. 979 MAIN STREET Acton , MA 01720 - |
| Product Code | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-21 |
| Decision Date | 1983-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810607000491 | K833266 | 000 |
| 00810607000026 | K833266 | 000 |
| 00810607000033 | K833266 | 000 |
| 00810607000040 | K833266 | 000 |
| 00810607000057 | K833266 | 000 |
| 00810607000064 | K833266 | 000 |
| 00810607000071 | K833266 | 000 |
| 00810607000088 | K833266 | 000 |
| 00810607000095 | K833266 | 000 |
| 00810607000101 | K833266 | 000 |
| 00810607000118 | K833266 | 000 |
| 00810607000125 | K833266 | 000 |
| 00810607000460 | K833266 | 000 |
| 00810607000477 | K833266 | 000 |
| 00810607000484 | K833266 | 000 |
| 00810607000019 | K833266 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACRA-CUT 81004466 1004466 Dead/Cancelled |
Intech Incorporated 0000-00-00 |
![]() ACRA-CUT 74123654 1663955 Dead/Cancelled |
Intech, Inc. 1990-12-12 |