The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for Laser Handpiece Shroud.
| Device ID | K930099 |
| 510k Number | K930099 |
| Device Name: | LASER HANDPIECE SHROUD |
| Classification | Powered Laser Surgical Instrument |
| Applicant | I.C. MEDICAL, INC. 2340 W. SHANGRI LA SUITE 202 Phoenix, AZ 85029 |
| Contact | Kurt Hasper |
| Correspondent | Kurt Hasper I.C. MEDICAL, INC. 2340 W. SHANGRI LA SUITE 202 Phoenix, AZ 85029 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-08 |
| Decision Date | 1993-07-28 |