The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for Penevac Abc Handpiece.
| Device ID | K955020 |
| 510k Number | K955020 |
| Device Name: | PENEVAC ABC HANDPIECE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | I.C. MEDICAL, INC. 5170 W. PHELPS RD. SUITE D Glendale, AZ 85306 |
| Contact | Kurt Hasper |
| Correspondent | Kurt Hasper I.C. MEDICAL, INC. 5170 W. PHELPS RD. SUITE D Glendale, AZ 85306 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-02 |
| Decision Date | 1996-04-09 |
| Summary: | summary |