The following data is part of a premarket notification filed by Dexcowin Co., Ltd. with the FDA for Cocoon Portable Handheld X-ray System.
| Device ID | K173046 |
| 510k Number | K173046 |
| Device Name: | Cocoon Portable Handheld X-Ray System |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Dexcowin Co., Ltd. #905, 2,, Gasan Digital 1-ro, GeumCheon-Gu Seoul, KR 08591 |
| Contact | Ryu Seung-bum |
| Correspondent | Joyce St. Germain Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2017-10-26 |
| Summary: | summary |