The following data is part of a premarket notification filed by Acra Cut, Inc. with the FDA for Acra-cut.
| Device ID | K944311 |
| 510k Number | K944311 |
| Device Name: | ACRA-CUT |
| Classification | Clip, Scalp |
| Applicant | ACRA CUT, INC. 989 MAIN ST. Acton, MA 01720 |
| Contact | Richard M Anderson |
| Correspondent | Richard M Anderson ACRA CUT, INC. 989 MAIN ST. Acton, MA 01720 |
| Product Code | HBO |
| CFR Regulation Number | 882.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1994-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810607000217 | K944311 | 000 |
| 00810607000200 | K944311 | 000 |
| 00810607000194 | K944311 | 000 |
| 00810607000187 | K944311 | 000 |
| 00810607000170 | K944311 | 000 |
| 00810607000163 | K944311 | 000 |
| 00810607000156 | K944311 | 000 |
| 00810607000149 | K944311 | 000 |
| 00810607000132 | K944311 | 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 |