The following data is part of a premarket notification filed by Hakko Shoji Co., Ltd. with the FDA for Lap Disc 120 X 120mm X 2cm #ld111; Lap Disc 120 X 120mm X 7cm #ld112.
| Device ID | K020307 |
| 510k Number | K020307 |
| Device Name: | LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | HAKKO SHOJI CO., LTD. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Elizabeth Miller |
| Correspondent | Elizabeth Miller HAKKO SHOJI CO., LTD. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-29 |
| Decision Date | 2002-04-26 |
| Summary: | summary |