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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Vaginal
510(k) Number K202542
Device Name Allura Vaginal Stent
Applicant
Pmt Corporation
1500 Park Rd.
Chanhassen,  MN  55317
Applicant Contact Matt Cree
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number884.3900
Classification Product Code
KXP  
Date Received09/02/2020
Decision Date 09/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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