The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Berkeley V-10 Vacuum Curettage System.
| Device ID | K030935 |
| 510k Number | K030935 |
| Device Name: | BERKELEY V-10 VACUUM CURETTAGE SYSTEM |
| Classification | System, Abortion, Vacuum |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Frank Fucile |
| Correspondent | Frank Fucile ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | HHI |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-25 |
| Decision Date | 2003-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925004481 | K030935 | 000 |
| 00821925004702 | K030935 | 000 |
| 00821925004689 | K030935 | 000 |
| 00821925001046 | K030935 | 000 |
| 00821925001039 | K030935 | 000 |
| 00821925001022 | K030935 | 000 |
| 00821925001015 | K030935 | 000 |
| 00821925000995 | K030935 | 000 |
| 00821925000988 | K030935 | 000 |
| 00821925000971 | K030935 | 000 |
| 00821925000964 | K030935 | 000 |
| 00821925000940 | K030935 | 000 |
| 00821925000919 | K030935 | 000 |
| 00821925008632 | K030935 | 000 |
| 00821925004184 | K030935 | 000 |
| 00821925010475 | K030935 | 000 |
| 00821925004719 | K030935 | 000 |
| 00821925004726 | K030935 | 000 |
| 00821925004207 | K030935 | 000 |
| 00821925004191 | K030935 | 000 |
| 00821925008625 | K030935 | 000 |
| 00821925004696 | K030935 | 000 |
| 00821925001008 | K030935 | 000 |
| 00821925000230 | K030935 | 000 |
| 00821925000223 | K030935 | 000 |
| 00821925000179 | K030935 | 000 |
| 00821925000032 | K030935 | 000 |
| 00821925004825 | K030935 | 000 |
| 00821925004818 | K030935 | 000 |
| 00821925004627 | K030935 | 000 |
| 00821925004610 | K030935 | 000 |
| 00821925004603 | K030935 | 000 |
| 00821925004597 | K030935 | 000 |
| 00821925009561 | K030935 | 000 |