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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K002830
Device Name PELVIC MUSCLE THERAPY
Applicant
Colonial Medical Supply
1350 E. Flamingo Rd. # 343
Las Vegas,  NV  89119
Applicant Contact PATRICIA LEIGH, R.N.
Correspondent
Colonial Medical Supply
1350 E. Flamingo Rd. # 343
Las Vegas,  NV  89119
Correspondent Contact PATRICIA LEIGH, R.N.
Regulation Number884.1425
Classification Product Code
HIR  
Date Received09/11/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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