The following data is part of a premarket notification filed by Hanuri Distribution, Inc with the FDA for Powerpress Unit.
| Device ID | K110276 |
| 510k Number | K110276 |
| Device Name: | POWERPRESS UNIT |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HANURI DISTRIBUTION, INC 9601 OWENSMOUTH AVENUE # 8 Chatsworth, CA 91311 |
| Contact | Jung Hyun Moon |
| Correspondent | Jung Hyun Moon HANURI DISTRIBUTION, INC 9601 OWENSMOUTH AVENUE # 8 Chatsworth, CA 91311 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-31 |
| Decision Date | 2011-11-09 |
| Summary: | summary |