The following data is part of a premarket notification filed by Hakko Medical Co., Ltd. with the FDA for Lap Disc 120 X 120mm X2cm, Model Ld111, Lap Disc 120 X 120mmx 7cm,model Ld112.
| Device ID | K030824 |
| 510k Number | K030824 |
| Device Name: | LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | HAKKO MEDICAL CO., LTD. 4545 CREEK RD. Cincinnati, OH 45242 |
| Contact | Elizabeth Miller |
| Correspondent | Elizabeth Miller HAKKO MEDICAL CO., LTD. 4545 CREEK RD. Cincinnati, OH 45242 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-14 |
| Decision Date | 2003-06-04 |
| Summary: | summary |