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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K253773
Device Name Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong
Applicant
Taizhou Huangyan Guanhong Plastic Steel Products Factory
Chengjiang St. Industrial Park, Huangyan District
Taizhou,  CN 318020
Applicant Contact Chenghao Lu
Correspondent
Taizhou Huangyan Guanhong Plastic Steel Products Factory
Chengjiang St. Industrial Park, Huangyan District
Taizhou,  CN 318020
Correspondent Contact Chenghao Lu
Regulation Number880.5570
Classification Product Code
MMK  
Date Received11/26/2025
Decision Date 05/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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