CORE-SPORT
Laparoscopic Single Port Access Device
Incore Co., Ltd.
The following data is part of a premarket notification filed by Incore Co., Ltd. with the FDA for Core-sport.
Pre-market Notification Details
| Device ID | K220081 |
| 510k Number | K220081 |
| Device Name: | CORE-SPORT |
| Classification | Laparoscopic Single Port Access Device |
| Applicant | Incore Co., Ltd. 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu, KR 41072 |
| Contact | Lee Jae-Hun |
| Correspondent | Lee Jae-Hun Incore Co., Ltd. 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu, KR 41072 |
| Product Code | OTJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-10 |
| Decision Date | 2022-09-28 |
Trademark Results [CORE-SPORT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORE-SPORT 77762063 4053457 Live/Registered |
Knit-Rite, Inc. 2009-06-17 |
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