The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Modular Laparoscopy Accessories, Handle; Sissors (straight And Curved); Grasper (aggressive, Allis, Ataumatic; Dissector.
| Device ID | K062337 |
| 510k Number | K062337 |
| Device Name: | MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Contact | Richard A Kozloff |
| Correspondent | Richard A Kozloff AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-10 |
| Decision Date | 2006-10-05 |
| Summary: | summary |