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 |