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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K253020
Device Name Strauss Surgical Resection Instruments
Applicant
American Medical Endoscopy, Inc.
3020 NW 82nd Ave.
Doral,  FL  33122
Applicant Contact Matthew Schwimmer
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Rob Packard
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Codes
FAJ   FAS  
Date Received09/19/2025
Decision Date 06/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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