The following data is part of a premarket notification filed by Jac-cell Medic Corporation with the FDA for Insulation And Continuity Tester Plus Accessories; Models Ati014 & Ati014 Fc.
| Device ID | K020334 |
| 510k Number | K020334 |
| Device Name: | INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | JAC-CELL MEDIC CORPORATION 7736 WOODSIDE COURT Maineville, OH 45039 |
| Contact | John Gagliardi |
| Correspondent | John Gagliardi JAC-CELL MEDIC CORPORATION 7736 WOODSIDE COURT Maineville, OH 45039 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-31 |
| Decision Date | 2002-10-03 |
| Summary: | summary |