The following data is part of a premarket notification filed by Acmi-circon Corporation with the FDA for Acmi Bipolar Rectoscope, Model Eiwe-br.
| Device ID | K021166 |
| 510k Number | K021166 |
| Device Name: | ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR |
| Classification | Resectoscope, Working Element |
| Applicant | ACMI-CIRCON CORPORATION 136 TURPIKE RD. Southborough, MA 01772 |
| Contact | John A Delucia |
| Correspondent | John A Delucia ACMI-CIRCON CORPORATION 136 TURPIKE RD. Southborough, MA 01772 |
| Product Code | FDC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-11 |
| Decision Date | 2002-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925007772 | K021166 | 000 |
| 00821925011229 | K021166 | 000 |
| 00821925001947 | K021166 | 000 |
| 00821925001374 | K021166 | 000 |