The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Acmi Disposable Bipolar Cord, Model Dbc.
| Device ID | K022480 |
| 510k Number | K022480 |
| Device Name: | ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC |
| Classification | Hysteroscope (and Accessories) |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | John A Delucia |
| Correspondent | John A Delucia ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-26 |
| Decision Date | 2002-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925010659 | K022480 | 000 |