The following data is part of a premarket notification filed by Andrews Surgical Innovations, Ltd. with the FDA for Andrews Introducer, Model Asi01.
| Device ID | K023173 |
| 510k Number | K023173 |
| Device Name: | ANDREWS INTRODUCER, MODEL ASI01 |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | ANDREWS SURGICAL INNOVATIONS, LTD. 16 GROVE LAWN MALAHIDE Co. Dublin, IE |
| Contact | Emmet Andrews |
| Correspondent | Emmet Andrews ANDREWS SURGICAL INNOVATIONS, LTD. 16 GROVE LAWN MALAHIDE Co. Dublin, IE |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-23 |
| Decision Date | 2002-12-18 |
| Summary: | summary |