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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K912462
Device Name Q-MS NEUROMUSCULAR STIMULATOR
Applicant
Quantitative Medicine, Inc.
1870 N. State Rd. 7
Matgate,  FL  33063
Applicant Contact YORK MCGAVIN
Correspondent
Quantitative Medicine, Inc.
1870 N. State Rd. 7
Matgate,  FL  33063
Correspondent Contact YORK MCGAVIN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/04/1991
Decision Date 06/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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