The following data is part of a premarket notification filed by Arvik Enterprises/ Mini Lap Technologies with the FDA for Arvik Laparoscopic Aspiration Instrument.
| Device ID | K102274 |
| 510k Number | K102274 |
| Device Name: | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Curtis Raymond |
| Correspondent | Curtis Raymond ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-11 |
| Decision Date | 2011-06-15 |
| Summary: | summary |