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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Replacement, Ossicular Prosthesis, Total
510(k) Number K260264
Device Name Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)
Applicant
Shanghai Medi Astro Technology Co., Ltd.
Rm. 1001, Bldg. 1
# 98, Fulian 1st Rd., Baoshan District
Shanghai,  CN 201906
Applicant Contact Bingbing Jie
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles Shen
Regulation Number874.3495
Classification Product Code
ETA  
Subsequent Product Code
ETB  
Date Received01/28/2026
Decision Date 10/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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