The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Valleylab Single Use Solid Laparoscopic Elec. Spatula (straight & Curved) J&l Hook, Ball Conmed Solid Shaft Electrode St.
| Device ID | K971674 |
| 510k Number | K971674 |
| Device Name: | VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Contact | J. Robert Saron |
| Correspondent | J. Robert Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-07 |
| Decision Date | 1997-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607151009110 | K971674 | 000 |
| 10607151007659 | K971674 | 000 |
| 10607151007642 | K971674 | 000 |
| 10607151007635 | K971674 | 000 |
| 10607151007628 | K971674 | 000 |
| 10607151007598 | K971674 | 000 |
| 10607151003163 | K971674 | 000 |
| 10607151003156 | K971674 | 000 |
| 10607151003149 | K971674 | 000 |
| 00607151007669 | K971674 | 000 |
| 10607151007673 | K971674 | 000 |
| 00607151009106 | K971674 | 000 |
| 10607151009097 | K971674 | 000 |
| 00607151009083 | K971674 | 000 |
| 10607151009073 | K971674 | 000 |
| 10607151009066 | K971674 | 000 |
| 10607151009059 | K971674 | 000 |
| 10607151009011 | K971674 | 000 |
| 10607151007680 | K971674 | 000 |
| 10607151003132 | K971674 | 000 |