The following data is part of a premarket notification filed by Acueity, Inc. with the FDA for Excisor Bioptome, Model 01-0004.
| Device ID | K032847 |
| 510k Number | K032847 |
| Device Name: | EXCISOR BIOPTOME, MODEL 01-0004 |
| Classification | Instrument, Biopsy |
| Applicant | ACUEITY, INC. 100 HAMILTON AVE., SUITE 140 Palo Alto, CA 94301 |
| Contact | Nancy Lince |
| Correspondent | P.n. Ruys N.V. KEMA P.O. BOX 9035 6800 ET ARNHEM Arnhem, NL |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-12 |
| Decision Date | 2003-09-26 |
| Summary: | summary |