The following data is part of a premarket notification filed by A & A Medical, Inc. with the FDA for Rocket Electrode.
| Device ID | K974138 |
| 510k Number | K974138 |
| Device Name: | ROCKET ELECTRODE |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | A & A MEDICAL, INC. 4100 NINE MCFARLAND DR., #B Alpharetta, GA 30201 |
| Contact | Jihad Mansour |
| Correspondent | Jihad Mansour A & A MEDICAL, INC. 4100 NINE MCFARLAND DR., #B Alpharetta, GA 30201 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-03 |
| Decision Date | 1998-01-30 |
| Summary: | summary |